Long QT Syndrome

Educational session will highlight how health system eased transition to new EHR with relevant, actionable medication decision support from FDB SOUTH SAN FRANCISCO, Calif., March 1, 2024 /PRNewswire/ -- FDB (First Databank, Inc.), the leading provider of drug knowledge that helps healthcare professionals make precise decisions, announces the success of its collaboration with NCH (Naples Comprehensive Health) in Southwest Florida. NCH has leveraged FDB solutions to optimize medication decision support, making alerts more meaningful and relevant to clinicians while significantly reducing overall alert volume. At the upcoming HIMSS24 conference in Orlando, David R. Linz, MD, Chief Medical Informatics Officer at NCH, will lead an educational session highlighting how the health system effectively integrated FDB Targeted Medication Warnings™ and FDB AlertSpace® solutions into its new electronic health record (EHR) system. The session will illuminate NCH's journey in enhancing medication decision support for improved patient safety, creating a more manageable workflow for physicians with less potential for alert fatigue. The NCH education session, titled " Introducing More Meaningful Medication Guidance While Tackling Alert Overload, " is scheduled for 1:30-2:30 pm ET, Tuesday, March 12, in W311A, West Building, Level 3 in the Orange County Convention Center in Orlando. In transitioning to a new EHR system, NCH physicians experienced a shift in their workflow, encountering non-critical-level medication decision support alerts for the first time. NCH recognized the potential burden this could pose to prescribers and sought to reduce the number of these alerts that would be presented to clinicians. They also recognized an opportunity to introduce optimized next-generation clinical decision support (CDS) that prioritizes actionable medication guidance specific to each patient. NCH turned to FDB for solutions in early 2023. Working collaboratively for just one hour a week over 12 weeks, the team implemented new targeted medication decision support based on a patient's unique clinical context. These "patient-first" medication decision support alerts for hyperkalemia, QT prolongation, opioids in an outpatient setting, and nephrotoxicity, in their generalized versions, were frequently dismissed by physicians due to lack of relevance to the patient's clinical status and other factors. By presenting medication alerts only when patient-specific parameters are met, in addition to customizing non-critical-level medication alerts and streamlining the alert development process, NCH successfully enhanced clinical relevance and reduced alert volume. The implementation yielded remarkable results, with related drug-drug interaction (DDI) alerts decreasing by up to 37.5%, and specific high-volume alerts dropping by as much as 94%. In only the first round of improvement, Dr. Linz estimates an overall reduction of 25% in medication CDS alerts per order, significantly alleviating alert fatigue among clinicians and improving workflow efficiency. He anticipates continued reductions with subsequent iterations review and optimization. The medication CDS optimization initiative has also contributed to NCH's improvement in its Leapfrog CPOE test results. To meet the CPOE standard set by the Leapfrog Hospital Survey on patient safety, hospitals must demonstrate, via the Leapfrog CPOE Evaluation Tool, that their inpatient CPOE systems can alert prescribers to at least 60% of frequent serious medication errors known to cause harm to patients. The Leapfrog CPOE Evaluation Tool also helps hospitals improve their use of CDS to reduce adverse drug events and improve medication safety. Dr. Linz emphasized, "Our collaboration with FDB has enabled us to deliver the right medication alerts at the right time, ensuring optimal patient care while minimizing clinician burden. By leveraging FDB's expertise and solutions, we eased the transition to our new EHR while achieving substantial improvements in patient safety and workflow efficiency and we were able to do so with fewer resources and in significantly less time." Furthermore, NCH will continue to rely on FDB for ongoing vetting and updating of medication decision support alert content, ensuring the delivery of timely and relevant information to clinicians. This partnership underscores NCH's commitment to enhancing patient safety and mitigating physician frustration associated with irrelevant alerts. Bob Katter, President of FDB, commented, "NCH Healthcare System's success story serves as a beacon for healthcare organizations grappling with alert fatigue and clinician burnout. By harnessing the power of FDB solutions, NCH has demonstrated exemplary leadership in delivering safe, high-quality care to their community." To learn more about NCH's journey and the impact of FDB solutions, attend Dr. Linz's educational session at HIMSS24 or visit FDB at booth #1747. About FDB FDB (First Databank) creates and delivers the world's most powerful drug knowledge that ignites, inspires, and illuminates critical medication decisions. We collaborate with our partners to help improve patient safety, operational efficiency, and health outcomes. Our drug databases drive healthcare information systems that serve the majority of hospitals, physician practices, pharmacies, payers, and all other areas of healthcare and are used by millions of clinicians, business associates, and patients every day. Please visit us at , or follow us on LinkedIn and YouTube. About Hearst Health The mission of Hearst Health is to help guide the most important care moments by delivering vital information into the hands of everyone who touches a person's health journey. Care guidance from Hearst Health reaches the majority of people in the U.S. The Hearst Health network includes FDB (First Databank), Zynx Health, MCG, Homecare Homebase, and MHK. Hearst also holds a minority interest in the precision medicine and oncology analytics company Aster Insights. Follow Hearst Health on LinkedIn @Hearst-Health. About NCH NCH (Naples Comprehensive Health) is a locally governed non-profit and an Advanced Community Health System™ located in Naples, Florida. The System is more than just two hospitals (referred to as the NCH Baker Hospital and NCH North Hospital) with a total of 713 beds. NCH is an alliance of 775 physicians and medical facilities in dozens of locations throughout Southwest Florida that offers nationally recognized, quality health care to our community. Our mission is to help everyone live a longer, happier, healthier life. For more information, visit . Contacts: Tara Stultz Amendola Communications for FDB M: 440-225-9595 [email protected] SOURCE FDB (First Databank)

PRINCETON, N.J.--( BUSINESS WIRE )-- U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for KRAZATI ® (adagrasib) in Combination with Cetuximab as a Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC) for Priority Review Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental new drug application (sNDA) for KRAZATI ® (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRAS G12C -mutated locally advanced or metastatic colorectal cancer (CRC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024. “Pretreated KRAS G12C -mutated CRC is associated with poor outcomes and the current standard of care offers limited clinical benefit for patients,” said Anne Kerber, senior vice president, head of late clinical development, Hematology, Oncology, Cell Therapy (HOCT) at Bristol Myers Squibb. “The acceptance of this filing for KRAZATI in combination with cetuximab is a positive step toward providing a potential new option for patients and their physicians. It reinforces our commitment to developing potentially transformative targeted cancer therapies for patients for whom few treatment options exist.” The submission is based on the results of KRYSTAL-1 study, a multicohort trial which evaluated KRAZATI alone or in combination with other anticancer therapies in patients with advanced solid tumors harboring a KRAS G12C mutation. The primary endpoint for the registrational cohort was objective response rate. The secondary endpoints for the pooled cohorts included duration of response, progression-free survival, overall survival and safety. Results of the KRYSTAL-1 study showed that KRAZATI was well tolerated and provided promising clinical activity in pretreated patients with locally advanced or metastatic CRC harboring a KRAS G12C mutation. The safety profile for KRAZATI plus cetuximab was manageable and consistent with previous reports, and with the known safety profile of each drug individually. ABOUT KRAZATI ® (adagrasib) KRAZATI (adagrasib) is highly selective and potent oral small-molecule inhibitor of KRAS G12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRAS G12C -mutated cancers, as the KRAS G12C protein regenerates every 24-48 hours. KRAS G12C mutations act as oncogenic drivers and occur in approximately 14% of NSCLC (adenocarcinoma), 3-4% of colorectal cancer, and 1-2% of several other cancers. In 2022, KRAZATI was granted accelerated approval for treatment of adult patients with KRAS G12C -mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s). In 2024, the European Commission (EC) granted conditional marketing authorization for KRAZATI as a targeted treatment option for adult patients with KRAS G12C -mutated advanced NSCLC and disease progression after at least one prior systemic therapy. KRAZATI continues to be evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRAS G12C -mutated solid tumors, including NSCLC and colorectal cancer. In 2022, the FDA granted breakthrough therapy designation for KRAZATI in combination with cetuximab in patients with KRAS G12C -mutated advanced colorectal cancer (CRC) whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy. For Prescribing Information, visit KRAZATI . ABOUT KRYSTAL-1 KRYSTAL-1 is an open-label, multicenter, multiple expansion cohort Phase 1/2 trial to determine the safety and efficacy of KRAZATI in patients with advanced solid tumors that harbor a KRAS G12C mutation. The primary endpoint for the Phase 2 cohort of the KRYSTAL-1 study was objective response rate. Secondary endpoints included duration of response, progression-free survival, overall survival and safety. INDICATION KRAZATI is indicated for the treatment of adult patients with KRAS G12C -mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION GASTROINTESTINAL ADVERSE REACTIONS In the pooled safety population, serious gastrointestinal adverse reactions observed were gastrointestinal obstruction in 1.6%, including 1.4% grade 3 or 4, gastrointestinal bleeding in 0.5% of patients, including 0.5% grade 3, and colitis in 0.3%, including 0.3% grade 3. In addition, nausea, diarrhea, or vomiting occurred in 89% of 366 patients, including 9% grade 3. Nausea, diarrhea, or vomiting led to dosage interruption or dose reduction in 29% of patients and permanent discontinuation of KRAZATI in 0.3% Monitor and manage patients using supportive care, including antidiarrheals, antiemetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue KRAZATI based on severity QTC INTERVAL PROLONGATION KRAZATI can cause QTc interval prolongation, which can increase the risk for ventricular tachyarrhythmias (eg, torsades de pointes) or sudden death In the pooled safety population, 6% of 366 patients with at least one post-baseline electrocardiogram (ECG) assessment had an average QTc ≥501 ms, and 11% of patients had an increase from baseline of QTc >60 msec. KRAZATI causes concentration-dependent increases in the QTc interval Avoid concomitant use of KRAZATI with other products with a known potential to prolong the QTc interval. Avoid use of KRAZATI in patients with congenital long QT syndrome and in patients with concurrent QTc prolongation Monitor ECGs and electrolytes prior to starting KRAZATI, during concomitant use, and as clinically indicated in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, and in patients who are taking medications that are known to prolong the QT interval. Withhold, reduce the dose, or permanently discontinue KRAZATI, depending on severity HEPATOTOXICITY KRAZATI can cause hepatotoxicity In the pooled safety population, hepatotoxicity occurred in 37%, and 7% were grade 3 or 4. A total of 32% of patients who received KRAZATI had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 5% were grade 3 and 0.5% were grade 4. Increased ALT/AST leading to dose interruption or reduction occurred in 11% of patients. KRAZATI was discontinued due to increased ALT/AST in 0.5% of patients Monitor liver laboratory tests (AST, ALT, alkaline phosphatase, and total bilirubin) prior to the start of KRAZATI, and monthly for 3 months or as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue KRAZATI based on severity INTERSTITIAL LUNG DISEASE /PNEUMONITIS KRAZATI can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal. In the pooled safety population, ILD/pneumonitis occurred in 4.1% of patients, 1.4% were grade 3 or 4, and 1 case was fatal. The median time to first onset for ILD/pneumonitis was 12 weeks (range: 5 to 31 weeks). KRAZATI was discontinued due to ILD/pneumonitis in 0.8% of patients Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Withhold KRAZATI in patients with suspected ILD/pneumonitis and permanently discontinue KRAZATI if no other potential causes of ILD/pneumonitis are identified ADVERSE REACTIONS The most common adverse reactions (≥25%) are nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, renal impairment, edema, dyspnea, decreased appetite FEMALES AND MALES OF REPRODUCTIVE POTENTIAL Infertility: Based on findings from animal studies, KRAZATI may impair fertility in females and males of reproductive potential Please see U.S. Full Prescribing Information for KRAZATI . About Colorectal Cancer Colorectal cancer (CRC) is cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. CRC is the third most commonly diagnosed cancer in the world. In 2020, it is estimated that there were approximately 1,931,000 new cases of the disease; it is the second leading cause of cancer-related deaths among men and women combined. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook and Instagram . Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that Krazati (adagrasib) in combination with cetuximab may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such combination treatment for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. It should be noted that acceptance of the application does not change the standards for FDA approval. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news

U.S. FDA has assigned a target action date of June 21, 2024 Application based on results from the Phase 1/2 KRYSTAL-1 study PRINCETON, N.J.--(BUSINESS WIRE)-- U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for KRAZATI® (adagrasib) in Combination with Cetuximab as a Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC) for Priority Review Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental new drug application (sNDA) for KRAZATI® (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024. “Pretreated KRASG12C-mutated CRC is associated with poor outcomes and the current standard of care offers limited clinical benefit for patients,” said Anne Kerber, senior vice president, head of late clinical development, Hematology, Oncology, Cell Therapy (HOCT) at Bristol Myers Squibb. “The acceptance of this filing for KRAZATI in combination with cetuximab is a positive step toward providing a potential new option for patients and their physicians. It reinforces our commitment to developing potentially transformative targeted cancer therapies for patients for whom few treatment options exist.” The submission is based on the results of KRYSTAL-1 study, a multicohort trial which evaluated KRAZATI alone or in combination with other anticancer therapies in patients with advanced solid tumors harboring a KRASG12C mutation. The primary endpoint for the registrational cohort was objective response rate. The secondary endpoints for the pooled cohorts included duration of response, progression-free survival, overall survival and safety. Results of the KRYSTAL-1 study showed that KRAZATI was well tolerated and provided promising clinical activity in pretreated patients with locally advanced or metastatic CRC harboring a KRASG12C mutation. The safety pro KRAZATI plus cetuximab was manageable and consistent with previous reports, and with the known safety pro each drug individually. ABOUT KRAZATI® (adagrasib) KRAZATI (adagrasib) is highly selective and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24-48 hours. KRASG12C mutations act as oncogenic drivers and occur in approximately 14% of NSCLC (adenocarcinoma), 3-4% of colorectal cancer, and 1-2% of several other cancers. In 2022, KRAZATI was granted accelerated approval for treatment of adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s). In 2024, the European Commission (EC) granted conditional marketing authorization for KRAZATI as a targeted treatment option for adult patients with KRASG12C-mutated advanced NSCLC and disease progression after at least one prior systemic therapy. KRAZATI continues to be evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC and colorectal cancer. In 2022, the FDA granted breakthrough therapy designation for KRAZATI in combination with cetuximab in patients with KRASG12C-mutated advanced colorectal cancer (CRC) whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy. For Prescribing Information, visit KRAZATI. ABOUT KRYSTAL-1 KRYSTAL-1 is an open-label, multicenter, multiple expansion cohort Phase 1/2 trial to determine the safety and efficacy of KRAZATI in patients with advanced solid tumors that harbor a KRASG12C mutation. The primary endpoint for the Phase 2 cohort of the KRYSTAL-1 study was objective response rate. Secondary endpoints included duration of response, progression-free survival, overall survival and safety. INDICATION KRAZATI is indicated for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION GASTROINTESTINAL ADVERSE REACTIONS In the pooled safety population, serious gastrointestinal adverse reactions observed were gastrointestinal obstruction in 1.6%, including 1.4% grade 3 or 4, gastrointestinal bleeding in 0.5% of patients, including 0.5% grade 3, and colitis in 0.3%, including 0.3% grade 3. In addition, nausea, diarrhea, or vomiting occurred in 89% of 366 patients, including 9% grade 3. Nausea, diarrhea, or vomiting led to dosage interruption or dose reduction in 29% of patients and permanent discontinuation of KRAZATI in 0.3% Monitor and manage patients using supportive care, including antidiarrheals, antiemetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue KRAZATI based on severity QTC INTERVAL PROLONGATION KRAZATI can cause QTc interval prolongation, which can increase the risk for ventricular tachyarrhythmias (eg, torsades de pointes) or sudden death In the pooled safety population, 6% of 366 patients with at least one post-baseline electrocardiogram (ECG) assessment had an average QTc ≥501 ms, and 11% of patients had an increase from baseline of QTc >60 msec. KRAZATI causes concentration-dependent increases in the QTc interval Avoid concomitant use of KRAZATI with other products with a known potential to prolong the QTc interval. Avoid use of KRAZATI in patients with congenital long QT syndrome and in patients with concurrent QTc prolongation Monitor ECGs and electrolytes prior to starting KRAZATI, during concomitant use, and as clinically indicated in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, and in patients who are taking medications that are known to prolong the QT interval. Withhold, reduce the dose, or permanently discontinue KRAZATI, depending on severity HEPATOTOXICITY KRAZATI can cause hepatotoxicity In the pooled safety population, hepatotoxicity occurred in 37%, and 7% were grade 3 or 4. A total of 32% of patients who received KRAZATI had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 5% were grade 3 and 0.5% were grade 4. Increased ALT/AST leading to dose interruption or reduction occurred in 11% of patients. KRAZATI was discontinued due to increased ALT/AST in 0.5% of patients Monitor liver laboratory tests (AST, ALT, alkaline phosphatase, and total bilirubin) prior to the start of KRAZATI, and monthly for 3 months or as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue KRAZATI based on severity INTERSTITIAL LUNG DISEASE /PNEUMONITIS KRAZATI can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal. In the pooled safety population, ILD/pneumonitis occurred in 4.1% of patients, 1.4% were grade 3 or 4, and 1 case was fatal. The median time to first onset for ILD/pneumonitis was 12 weeks (range: 5 to 31 weeks). KRAZATI was discontinued due to ILD/pneumonitis in 0.8% of patients Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Withhold KRAZATI in patients with suspected ILD/pneumonitis and permanently discontinue KRAZATI if no other potential causes of ILD/pneumonitis are identified ADVERSE REACTIONS The most common adverse reactions (≥25%) are nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, renal impairment, edema, dyspnea, decreased appetite FEMALES AND MALES OF REPRODUCTIVE POTENTIAL Infertility: Based on findings from animal studies, KRAZATI may impair fertility in females and males of reproductive potential Please see U.S. Full Prescribing Information for KRAZATI. About Colorectal Cancer Colorectal cancer (CRC) is cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. CRC is the third most commonly diagnosed cancer in the world. In 2020, it is estimated that there were approximately 1,931,000 new cases of the disease; it is the second leading cause of cancer-related deaths among men and women combined. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that Krazati (adagrasib) in combination with cetuximab may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such combination treatment for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. It should be noted that acceptance of the application does not change the standards for FDA approval. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news View source version on businesswire.com: Contacts Bristol Myers Squibb Media Inquiries: media@bms.com Investors: investor.relations@bms.com Source: Bristol Myers Squibb View this news release online at: