The FDA has reduced monitoring requirements around the first two Imdelltra doses, lowering an important logistical burden days after Amgen reported positive Phase 3 survival data in first-line extensive-stage small cell lung cancer.
Amgen’s Phase 3 DeLLphi-305 trial met its primary overall survival endpoint with Imdelltra plus Imfinzi as first-line maintenance in extensive-stage small cell lung cancer.
Alvotech can receive up to about $150 million while retaining the right to sell AVT34 and AVT87 itself in the United States, a first for its US biosimilar strategy.
Imfinzi has FDA approval with BCG in early high-risk bladder cancer. The next test is adoption, recurrence data and real-world use.
Imfinzi moves into early bladder cancer, but can AstraZeneca turn a DFS win into real-world bladder-preserving impact?
Stomach cancer care gains immunotherapy, but NHS adoption now depends on surgery timing, toxicity management and recurrence data.
Explore what AIM ImmunoTech’s Ampligen Phase 2 data could change for pancreatic cancer immunotherapy and what risks still remain.