Lapatinib Ditosylate Hydrate

YANTAI, China, Dec. 12, 2024 /PRNewswire/ -- On the morning of December 12, 2024 (UTC-6), at the Poster Spotlight Session "Novel HER2 Therapeutics" of the 47th San Antonio Breast Cancer Symposium (SABCS), RemeGen Co. Ltd. ("RemeGen") (9995.HK, 688331.SH) presented for the first time the data from a phase III study (RC48-C006, NCT03500380) of Disitamab Vedotin (DV) in treating patients with HER2-positive advanced breast cancer with liver metastasis (BCLM). This is the first prospective randomized phase III study globally on a HER2-targeting ADC that demonstrated significant efficacy in patients with HER2-positive advanced BCLM. Professor Jiayu Wang from the Cancer Hospital, Chinese Academy of Medical Sciences presented and discussed the study. SABCS is one of the largest and most influential annual conferences focusing on advances in breast cancer clinical research, and this RemeGen sponsored study attracted the attention of experts worldwide. Data shows that about 45% of patients with HER2-positive advanced breast cancer have liver metastasis. This subset has a poor prognosis with a 5-year survival rate of only 8% to 12%, for whom no satisfactory therapies are available now. This is a randomized, open-label, multicenter phase III study comparing the efficacy and safety of DV versus Lapatinib plus Capecitabine in patients with HER2-positive advanced BCLM. A total of 104 patients were enrolled, of whom 53 received DV and 50 received Lapatinib plus Capecitabine. All patients had previously been treated with Trastuzumab and Taxanes. As of data cutoff date (December 31, 2023), according to the assessment by the Independent Review Committee (IRC), DV significantly improved progression-free survival (PFS) versus Lapatinib plus Capecitabine (median: 9.9 months vs. 4.9 months; hazard ratio [HR]: 0.56 [95% CI: 0.35-0.90]), which is consistent with the investigator-assessed PFS (HR: 0.62 [95% CI: 0.39-0.98]). The overall survival (OS) data, though immature, indicated a benefit trend in favor of DV. The safety profile was consistent with past DV use experience, with no new safety signals detected. "This is the first confirmatory phase III study that demonstrated promising efficacy of an HER2-targeting ADC in patients with HER2-positive advanced BCLM," observed Professor Jiayu Wang. DV demonstrated clinically meaningful benefit compared with Lapatinib plus Capecitabine and a manageable safety profile, potentially offering a promising new treatment option for patients with HER2-positive advanced BCLM previously treated with Trastuzumab and Taxanes. The Biologics License Application (BLA) filing for this indication of DV has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration in October 2024 and priority review was granted based on the breakthrough therapy designation. SOURCE RemeGen Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

On February 25, 2020, the Food and Drug Administration approved neratinib (NERLYNX, Puma Biotechnology, Inc.) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. Efficacy of neratinib with capecitabine was investigated in NALA (NCT01808573), a randomized, multicenter, open-label clinical trial in 621 patients with metastatic HER2-positive breast cancer who received two or more prior anti-HER2 based regimens in the metastatic setting. Patients were randomized (1:1) to receive neratinib 240 mg orally once daily on days 1-21 with capecitabine 750 mg/m2 given orally twice daily on days 1-14 for each 21-day cycle (n=307) or lapatinib 1250 mg orally once daily on days 1-21 with capecitabine 1000 mg/m2 given orally twice daily on days 1-14 for each 21-day cycle (n=314). Patients were treated until disease progression or unacceptable toxicity. The primary efficacy outcome measures were progression-free survival (PFS), assessed by a blinded independent central review per RECIST v1.1, and overall survival (OS). Key secondary outcome measures were objective response rate (ORR) and response duration. Median PFS was 5.6 months (95% CI: 4.9, 6.9) for patients who received neratinib with capecitabine and 5.5 months (95% CI: 4.3, 5.6) for those receiving lapatinib with capecitabine (hazard ratio 0.76; 95% CI: 0.63, 0.93; p=0.0059). The PFS rate at 12 months was 29% (95% CI: 23, 35) vs 15% (95% CI: 10, 20), respectively. Median OS was 21 months (95% CI: 17.7, 23.8) for patients receiving neratinib with capecitabine compared to 18.7 months (95% CI: 15.5, 21.2) for those receiving lapatinib plus capecitabine (HR 0.88; 95% CI: 0.72, 1.07; p=0.2086). The ORR was 32.8% (95% CI: 27.1, 38.9) vs 26.7% (95% CI: 21.5, 32.4), respectively. Median response duration was 8.5 (95% CI: 5.6, 11.2) vs 5.6 months (95% CI: 4.2, 6.4), respectively. The most common adverse reactions of any grade (>5%) in the neratinib plus capecitabine arm were diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. The most frequently reported Grade 3 or 4 adverse reactions were diarrhea, nausea, vomiting, fatigue and decreased appetite. The recommended neratinib dose for advanced or metastatic breast cancer is 240 mg (6 tablets) given orally once daily with food on days 1-21 of a 21-day cycle plus capecitabine (750 mg/m2 given orally twice daily) on days 1-14 of a 21-day cycle until disease progression or unacceptable toxicities. View full prescribing information for NERLYNX. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was approved 2 months prior to the FDA goal date. Neratinib was granted Fast Track designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. Follow the Oncology Center of Excellence on Twitter @FDAOncologyExternal Link Disclaimer. Content current as of: 02/26/2020 Regulated Product(s) Drugs 02/26/2020 Drugs Resources for Information | Approved Drugs Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description