Phase III
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.
Antibody-drug conjugate Adcetris, when used with rituximab or lenalidomide, improved overall survival in patients with relapsed or refractory diffuse large B-cell lymphoma. Pfizer secured access to Seagen’s ADC in March 2023.
Friday’s topline data from the Phase III PHOENIX trial of Relyvrio, which won approval in 2022, showed no significant difference on either the primary or secondary endpoints, according to Amylyx.
The antibody-drug conjugate beat the standard of care in second-line multiple myeloma, the company reported on Thursday, as it seeks to get the cancer drug back on the U.S. market.
The recently launched company shared two posters at the Muscular Dystrophy Association’s annual conference this week ahead of a March 21 PDUFA date.
After stopping the study early due to strong efficacy, Novo Nordisk released data from the FLOW study showing significant benefits of semaglutide in patients with type 2 diabetes and chronic kidney disease.
As BridgeBio’s acoramidis inches closer to an FDA approval decision, Bayer on Monday inked a European licensing agreement for the transthyretin amyloid cardiomyopathy treatment.
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