Final overall survival data for RYBREVANT plus chemotherapy in EGFR exon 20 insertions and tolerability updates for subcutaneous RYBREVANT FASPRO with prophylactic strategies.
Tarlatamab (IMDELLTRA) plus durvalumab showed statistically significant OS, PFS and ORR benefits versus durvalumab alone in Phase 3 DeLLphi‑305 for first‑line maintenance ES‑SCLC.
OrigAMI-4 showed 42% response rate with >1/3 complete responses; FDA review shortened to ~6 months; drug targets EGFR and MET and is co-formulated with hyaluronidase.
Three Phase III trials will test DLL3-targeting obrixtamig in SCLC and epNEC, and HER2 TKI zongertinib as adjuvant therapy in resectable HER2‑mutant NSCLC.
FDA accepted an sBLA for adjuvant PD‑L1 therapy plus chemotherapy in stage III dMMR/MSI‑H colon cancer; agency decision expected Oct 9, 2026.
Phase 1b/2 OrigAMI-4: subcutaneous amivantamab + hyaluronidase achieved 42% ORR (15% CR) in pretreated recurrent/metastatic HNSCC; median DOR not reached (11.8 mo FU); manageable safety.
European Commission approves subcutaneous RYBREVANT® for flexible dosing in advanced EGFR-mutated NSCLC, offering reduced clinic time and fewer reactions.
FDA grants Breakthrough Therapy Designation to RYBREVANT FASPRO™ for HPV-unrelated head and neck cancer after platinum-based chemotherapy and PD-1/PD-L1 inhibitor.
Merck's KANDLELIT-007 trial tests calderasib and KEYTRUDA QLEX for KRAS G12C-mutant NSCLC, focusing on progression-free survival and overall response.
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