12/06/2026 Jazz Pharmaceuticals' Zepzelca Phase 3 LAGOON Trial Misses Primary Endpoint in Second-Line SCLC AbbVie's Venetoclax Shows Sustained 9-Year Efficacy in First-Line CLL at EHA 2026 Jazz Pharmaceuticals' Zepzelca Phase 3 LAGOON Trial Misses Primary Endpoint in Second-Line SCLC (Ref) The Phase 3 LAGOON trial, evaluating Zepzelca (lurbinectedin) in relapsed/second-line metastatic small cell lung cancer (SCLC), did not meet its primary endpoint of overall survival (OS) fo

13/04/2026 FDA issues Complete Response Letter to Replimune’s RP1 BLA, halting accelerated approval path FDA Grants Priority Review for Ifinatamab Deruxtecan in ES-SCLC Daraxonrasib Demonstrates Unprecedented Survival Benefit in Phase 3 Pancreatic Cancer Trial Jaypirca (pirtobrutinib) combination significantly extended progression-free survival (PFS) in Relapsed/Refractory CLL/SLL SynOx Therapeutics' Phase 3 TANGENT Study Delivers Positive Results for TGCT Treatment IDEAYA an

24/02/2026 Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC Siren Biotechnology's SRN-101 received the FDA fast track designation for HGG Aktis Oncology's AKY-1189 received the FDA fast track designation for mUC Onconic Therapeutics' nesuparib received the FDA orphan drug designation for SCLC Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC (Ref) The US FDA granted traditional approval to Pfizer's encorafenib

10/12/2025 GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC Ajax Therapeutics' AJ1-11095 received the FDA orphan drug designation for myelofibrosis GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC (Ref) The US FDA granted the orphan drug designation to GSK's risvutatug rezetecan (B7-H3-targeted ADC) for the treatment of small-cell lung cancer (SCLC). The ODD was based on preliminary clinical data of the Phase 1 ARTEMIS-0

18/08/2025 Izalontamab brengitecan received the Breakthrough Therapy Designation by the US FDA for EGFR-mutated NSCLC (Ref) The US FDA granted the Breakthrough Therapy Designation to SystImmune and Bristol Myers Squibb's izalontamab brengitecan (EGFR x HER3 bispecific ADC) for the treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI and platinum