Relay Therapeutics reported Q4/FY 2025 results, outlined 2026 milestones for zovegalisib, and held ~$555M in cash. Initial vascular anomaly data and breast cancer triplet data are expected in 2026.
Clinical trial results support ctDNA-guided therapy for bladder cancer, with the phase III IMvigor011 trial showing improved survival outcomes. Standardisation efforts are underway through position papers from professional societies and consensus guidelines. Nanotechnology advances and AI integration are poised to improve ctDNA detection sensitivity for liquid biopsy applications.
The FDA has approved Pfizer's BRAFTOVI for BRAF V600E metastatic colorectal cancer and VEPPANU for ESR1 mutated breast cancer. The oncolytic virus cancer therapy pipeline expands with over 120 companies developing 125+ drugs. Positive late-stage data for other Pfizer oncology programs was also reported.
The FDA replaced the two-trial approval requirement with a single pivotal trial standard, launched an AI pilot with AstraZeneca and Amgen, and extended the camizestrant review. A key FDA official is departing. AstraZeneca posted $58.74 billion in revenue.
The FDA extended the review deadline for AstraZeneca's camizestrant and issued a complete response letter for its COPD drug PT010. The agency also adopted a single-pivotal-trial approval policy, while AstraZeneca sold Losec rights to Cheplapharm.
The FDA has accepted the New Drug Application for giredestrant plus everolimus in ESR1-mutated, ER-positive, HER2-negative advanced breast cancer. The filing is based on Phase III evERA data showing reduced risk of disease progression or death versus standard-of-care endocrine therapy plus everolimus.
A Labcorp Drug Development medical director shared insights on MRD testing in lung cancer, breast cancer precision strategies, and cancer research for minority populations. She highlighted a Fox Chase Cancer Center collaboration for an ultra-sensitive MRD assay and discussed progress in ESR1 mutations and oral SERDs.
FDA has accepted the NDA for vepdegestrant (ARV-471), an oral PROTAC ER degrader from Arvinas and Pfizer, for ESR1-mutated ER+/HER2- advanced breast cancer. A PDUFA date of June 5, 2026 has been set. The submission is based on positive Phase 3 VERITAC-2 data.
FDA's ODAC voted 6-3 against AstraZeneca's camizestrant for HR+/HER2- metastatic breast cancer, citing uncertain clinical benefit from the SERENA-6 trial design. The FDA raised concerns about the early-switch treatment paradigm and long-term outcomes.
Recent studies demonstrate high response rates for antibody-drug conjugate in rare blood cancer, improved outcomes with metastasis-directed radiation in prostate cancer, and a novel drug combination strategy for ovarian cancer resistance.
