Phase III
Imagine testing a really good drug for HER2+ breast cancer in someone with liver cancer. Would it be any surprise when that drug fails?
Keytruda, when used with AstraZeneca’s Lynparza, did not significantly improve overall and progression-free survival in specific patients with metastatic non-squamous non-small cell lung cancer.
The recent FDA decision will likely mean more Medicare patients gain access to the blockbuster weight loss drug, experts say. Meanwhile, results continue to roll in for GLP-1 agonists for conditions beyond diabetes and obesity.
In advance of a March 21 PDUFA date, Italfarmaco on Tuesday reported that its drug candidate givinostat met the primary endpoint for treating Duchenne muscular dystrophy.
Bristol Myers Squibb secured another late-phase immuno-oncology victory Wednesday, showing that the combination of Opdivo and Yervoy improved overall survival in a patient population served by rival checkpoint inhibitors from AstraZeneca and Roche.
Bayer bagged another late-stage victory for its menopause drug candidate Tuesday, setting up a potential showdown with Astellas’ Veozah which was approved last year by the FDA for the treatment of hot flashes.
The biotech Tuesday reported that 56% of patients taking paltusotine in a late-stage trial achieved the primary endpoint of IGF-1 levels for their rare hormonal disorder. An NDA submission is slated for later this year with a launch anticipated in 2025.
AstraZeneca reported Monday that adding Lynparza to Imfinzi improved outcomes in mismatch repair proficient endometrial cancer, more than doubling the median duration of response in patients.
New late-stage trial results for GSK’s Jemperli show improved overall and progression-free survival in a broader range of endometrial cancer patients, which could lead to a potential label expansion.
The PD-1 inhibitor Keytruda significantly improved overall survival in a late-stage trial when used with chemoradiotherapy to treat patients with newly diagnosed advanced cervical cancer.
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