Dapagliflozin

The FDA has approved AstraZeneca’s Imfinzi to treat limited-stage small cell lung cancer, adding another lung cancer indication to one of the pharma’s best-selling drugs. The decision, announced by the company Thursday, is based on Phase 3 data showing that Imfinzi reduced the risk of death in patients with SCLC by 27% compared to placebo. Patients who received treatment had a median overall survival of 55.9 months compared to 33.4 months for those on placebo. AstraZeneca found that 57% of patients given Imfinzi were alive at three years, compared to 48% for placebo. The approval applies to patients whose disease has not progressed after receiving platinum-based chemotherapy and radiation therapy. Suresh Senan, international coordinating investigator for the trial and a professor of radiotherapy at Amsterdam University Medical Centers, called the data “the first advance for this disease in four decades,” according to a statement. Limited-stage SCLC means that cancer is contained within one side of the lung and has not yet spread elsewhere. About a third of small cell lung cancer patients have limited-stage disease when the cancer is first identified, according to the American Cancer Society. Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, said Imfinzi is the only immunotherapy approved for both limited- and extensive-stage small cell lung cancer. The latest approval comes after the FDA approved Imfinzi in August to treat certain patients with non-small cell lung cancer before surgery in combination with chemotherapy, and also after surgery as a monotherapy. That decision came despite FDA advisors requesting that drugmakers design more informative trials around surgery. Imfinzi was AstraZeneca’s third highest-selling drug in the third quarter , behind Tagrisso and cardiometabolic drug Farxiga. The multibillion-dollar immunotherapy has raked in nearly $3.5 billion in revenue through the first nine months of the year.

With around $2 billion of the investment dedicated to creating more than a thousand U.S. jobs, AstraZeneca is looking to expand R&D and manufacturing facilities in states including Massachusetts, Maryland, and Texas dedicated to specialty manufacturing, biologics and cell therapies. The £158.7 billion ($200.8 billion) market-cap player is among the top ten biggest pharmaceutical companies in the world, with landmark products including the small molecule diabetes drug dapagliflozin (Farxiga) and cancer medications osimertinib (Tagrisso) and acalabrutinib (Calquence). AstraZeneca’s latest investment in the U.S. comes as part of the company’s mission to expand its research and manufacturing capabilities by the end of 2026 and to hit $80 billion in total revenue by 2030. “Our multibillion dollar investment reflects the attractiveness of the business environment together with the quality of talent and innovation capabilities here in the United States,” said AstraZeneca CEO Pascal Soriot in a public statement ​. “By expanding our R&D and manufacturing footprint, we aim to enhance the development of cutting-edge therapies and support the United States leadership in healthcare innovation.” AstraZeneca’s move echoes those of other pharmaceutical firms increasing their foothold in the lucrative U.S. market, which makes up 44% of AstraZeneca’s revenue. For example, GSK recently sank ​ $800 million into a site in Pennsylvania to double its capacity, while Novo Nordisk earmarked $4.1 billion for a new manufacturing facility in North Carolina earlier this year ​. googletag.cmd.push(function () { googletag.display('text-ad1'); }); AstraZeneca unveiled a 19% increase in its total revenue to $39.1 billion over the last nine months in a recent earnings report ​, which was driven by growth in product sales and income from partnered candidates. The firm now sees high teens percentage growth in its total revenue for the whole year 2024. Some of the biggest earners for AstraZeneca this year include Farxiga with $5.7 billion, Tagrisso with $4.8 billion and durvalumab (Imfinzi) with $3.4 billion. However, it is not all smooth sailing for the big pharma company, with some of its current and former employees, including EVP International and AstraZeneca China President Leon Wang, under investigation in China with allegations of medical insurance fraud, illegal drug importation and personal information breaches. “We take the matters in China very seriously. If requested we will fully cooperate with the authorities,” stated Soriot in the earnings report.