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

30/03/2026 Zymeworks' ZW191 ADC received the FDA fast track designation for PROC Elevar Therapeutics' NDA for lirafugratinib received priority review status from the FDA for cholangiocarcinoma Henlius Biotech's serplulimab + chemo received positive CHMP opinion for NSCLC and ESCC Zymeworks' ZW191 ADC received the FDA fast track designation for PROC (Ref) The US FDA granted the fast track designation to Zymeworks Inc's ZW191 (FRα-targeting ADC) for the treatment of patients

18/02/2026 ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS Johnson & Johnson's subcutaneous amivantamab received the FDA Breakthrough Therapy Designation for HPV-unrelated R/M SCCHN ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS (Ref) The EC granted conditional marketing authorization to ImmunityBio's ANKTIVA® (nogapendekin alfa inbakicept) +

17/02/2026 Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL J&J's RYBREVANT FASPRO™ received FDA approval for once a month dosing schedule for EGFRm NSCLC BMS' NDA for iberdomide + standard treatment has been accepted by the US FDA for R/R MM Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL (Ref) The US FDA has accepted for filing the NDA under the accelerated approval pathway for Deciph

21/01/2026 BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 Wugen's soficabtagene geleucel received the FDA Breakthrough Therapy Designation for T cell malignancies Opna Bio's zavabresib received the FDA orphan drug designation for myelofibrosis BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 (Ref) The US FDA granted the fast track designation to BioNTech's BNT11

29/12/2025 HUTCHMED's fanregratinib received priority review status in China for second-line intrahepatic cholangiocarcinoma Genmab discontinued the clinical development of acasunlimab following a portfolio review HUTCHMED's fanregratinib received priority review status in China for second-line intrahepatic cholangiocarcinoma (Ref) China's NMPA accepted and granted priority review status to HUTCHMED Limited's NDA for fanregratinib (FGFR 1/2/3 inhibitor) for the treatment of a

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

08/12/2025 Chimeric Therapeutics' CHM CDH17 received the FDA orphan drug designation for Gastric Cancer Chimeric Therapeutics' CHM CDH17 received the FDA orphan drug designation for Gastric Cancer (Ref) The US FDA granted the orphan drug designation to Chimeric Therapeutics' CHM CDH17 (CDH17-targeting CAR-T cell therapy) in the treatment of Gastric Cancer. Dr Rebecca McQualter, CEO, Chimeric Therapeutics: “This is a great step forward in the development of CHM CDH17 to serve

01/12/2025 Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia Astellas Pharma and Pfizer's Type II variation application for perioperative enfortumab vedotin + pembro has been valiated by the EMA Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia (Ref) The US FDA granted the fast track designation to Cullinan Therapeutics' CLN-049 (FLT3 x CD3 bispecific T cell engager) for th

17/11/2025 Dewpoint Therapeutics' DPTX3186 received the FDA fast track designation for gastric cancer (Ref) The US FDA granted the fast track designation to Dewpoint Therapeutics' DPTX3186 (oral condensate modulator) for the treatment of gastric cancer. Isaac Klein, CSO and Head of R&D, Dewpoint Therapeutics: “We are honored that the FDA has recognized the urgency of gastric cancer and the promise of our condensate-based approach. DPTX3186 represents a new way of modulating d

11/08/2025 IO Biotech's Cylembio + pembrolizumab demonstrated clinical improvement in PFS as a first-line treatment of Melanoma, but statistical significance was narrowly missed (Ref) IO Biotech announced topline results from the pivotal Phase 3 IOB-013 trial of Cylembio (imsapepimut and etimupepimut, adjuvanted; IDO and PD-L1 vaccine) + pembrolizumab vs pembrolizumab alone as a first-line treatment of advanced melanoma. The combo demonstrated clinical improvement in PFS vs p

07/08/2025 ProteinQure's PQ203 received the Fast track designation for TNBC (Ref) The US FDA granted the Fast Track designation to ProteinQure's PQ203 (SORT1 targeting peptide drug conjugate) for the treatment of patients with triple negative breast cancer. ProteinQure also received regulatory clearance from both the US FDA and Health Canada to initiate a Phase 1 trial evaluating the safety, pharmacokinetics, pharmacodynamics and anti-cancer activity of PQ203 The Phase 1 stud

24/07/2025 GenFleet Therapeutics and Verastem Oncology's VS-7375 received the Fast Track Designation from the US FDA for pancreatic cancer (Ref) The US FDA granted the Fast Track Designation to GenFleet Therapeutics and Verastem Oncology's VS-7375 (oral KRAS G12D (ON/OFF) inhibitor) for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas, and for the treatment of patients with KRAS G12D-mutated locally adva

22/07/2025 Replimune's BLA for vusolimogene oderparepvec + nivo received a CRL from the US FDA (Ref) The US FDA issued a Complete Response Letter (CRL) regarding the BLA for Replimune's vusolimogene oderparepvec (RP1; herpes simplex virus engineered with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivolumab for the treatment of advanced melanoma. The CRL highlighted that the FDA was unable to approve the application in its present form due to the following reasons: The Ph1

12/06/2025 MAIA Biotechnology and Roche announce a master clinical supply agreement for hard-to-treat cancer therapies (Ref) MAIA Biotechnology entered into a clinical master supply agreement with Roche for future trials evaluating MAIA’s ateganosine (THIO; telomere-targeting agent) in combination with Roche's atezolizumab (Tecentriq; anti-PD-L1) for the treatment of multiple hard-to-treat cancers. Ateganosine's highly synergistic and effective activity in combination with at