#辉瑞

#辉瑞

Today 0 items

Oct 8Thu

Thursday

02:33
fda.govPickScore8080
FDA approves tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancer
The FDA approved tucatinib (Tukysa, Seagen, a Pfizer subsidiary) with trastuzumab and pertuzumab on October 7, 2026, for maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer after induction therapy. In the 654-patient HER2CLIMB-05 trial, median progression-free survival was 24.9 months with tucatinib 300 mg twice daily versus 16.3 months with placebo (HR 0.64, p<0.0001). The label carries a boxed warning for hepatotoxicity; overall survival data were immature.
Regulatory #Regulatory #Oncology #Pfizer
Why it matters: FDA approval extends tucatinib to first-line maintenance, with PFS results from a randomized phase 3 trial.

Aug 28Fri

Friday

05:38
fiercepharma.comPickScore7373
Priovant pushes ex-Pfizer asset across FDA finish line in rare skin and muscle disease
The FDA has approved Priovant Therapeutics' brepocitinib, to be marketed as Lisraya, a once-daily pill for adults with dermatomyositis, making it the first targeted therapy approved in the disease. The approval rests on the phase 3 Valor trial of 241 patients, where the high dose achieved a mean Total Improvement Score of 46.5 versus 31.2 for placebo, with 55% of treated patients reaching moderate or better improvement with minimal or no steroid use versus 30% on placebo. The Roivant-backed company, formed in 2022 with a Pfizer deal, is also testing the dual TYK2/JAK1 inhibitor in phase 3 noninfectious uveitis and cutaneous sarcoidosis.
Regulatory #Regulatory #Autoimmunity #FDA
Why it matters: First FDA approval of a targeted therapy for dermatomyositis, for a company's debut drug with further late-stage indications underway.