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FDA Rejects RP1 for Advanced Melanoma, Says IGNYTE Not a ‘Well-Controlled’ Trial
FDA · United States

FDA Rejects RP1 for Advanced Melanoma, Says IGNYTE Not a ‘Well-Controlled’ Trial

67% Center coverage: 3 sources
The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license application for vusolimogene oderparepvec in combination with nivolumab for the treatment of advanced melanoma.According to a company press release, the letter indicates that the FDA cannot approve the application for vusolimogene oderparepvec (RP1) — the company’s leadSee the Story
AbbVie Files to Move Venclexta Combo Into the CLL Front Line
United States · United States

AbbVie Files to Move Venclexta Combo Into the CLL Front Line

Coverage: 2 sources
AbbVie has filed for FDA approval of a new front-line therapy for chronic lymphocytic leukaemia that it thinks could be 'practice changing."See the Story
Pirtobrutinib Yields Noninferior ORR Vs Ibrutinib in CLL/SLL

Pirtobrutinib Yields Noninferior ORR Vs Ibrutinib in CLL/SLL

Data from the phase 3 BRUIN CLL-314 trial show a progression-free survival trend favoring pirtobrutinib compared with ibrutinib in patients with CLL/SLL.See the Story

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