15/10/2026 US FDA grants second Fast Track Designation to Invikafusp Alfa in checkpoint-refractory TMB-High solid tumors Revolution Medicines' RASONQUE receives positive CHMP opinion for Metastatic Pancreatic Cancer US FDA grants second Fast Track Designation to Invikafusp Alfa in checkpoint-refractory TMB-High solid tumors (Ref) Marengo Therapeutics announced that the US FDA has granted a second Fast Track Designation (FTD) to Invikafusp alfa (STAR0602; bispecific dual T-cel

14/10/2026 ImmunityBio secures US FDA expansion for ANKTIVA in BCG-Unresponsive Papillary Bladder Cancer Tab-cel BLA resubmission accepted by US FDA for EBV+ PTLD; PDUFA date set for March 2027 ImmunityBio secures US FDA expansion for ANKTIVA in BCG-Unresponsive Papillary Bladder Cancer (Ref) The US FDA expanded the approval of ANKTIVA® (nogapendekin alfa inbakicept-pmln; IL-15 receptor agonist) in combination with BCG to include patients with BCG-unresponsive non-muscle-inva

13/10/2026 US FDA accepts FYB206 for review as proposed Keytruda Biosimilar US FDA accepts FYB206 for review as proposed Keytruda Biosimilar (Ref) FYB206, a proposed biosimilar to Keytruda® (pembrolizumab), has been accepted for review by the US FDA, representing the first publicly announced FDA acceptance of a Keytruda biosimilar application The application was submitted by Formycon, with Zydus holding exclusive commercialization rights in the US and Canada US FDA accepted t

12/10/2026 Opamtistomig (PD-L1 x 4-1BB BsAb) receives US FDA Fast Track Designation in First-Line Biliary Tract Cancer In Phase 3 ACTION-1 trial, RYZ101 met primary endpoint of PFS in patients with GEP-NETs HLB/Elevar Resubmits US FDA application for first-line Liver Cancer combination US FDA grants Fast Track Designation to AST-301 for HER2-Positive Gastric Cancer Opamtistomig (PD-L1 x 4-1BB BsAb) receives US FDA Fast Track Designation in First-Line Biliary Tract Cancer (Ref

11/10/2026 EMA validates aumolertinib MAA, initiating EU review in EGFR-mutated NSCLC EMA validates aumolertinib MAA, initiating EU review in EGFR-mutated NSCLC (Ref) Hansoh announced resubmission of the EU Marketing Authorization Application (MAA) for aumolertinib (EGFR-TKI) to the European Medicines The EMA validated the application on October 7, 2026 and the centralized regulatory review process has officially begun The application seeks approval for two EGFR-mutated NSCLC

08/10/2026 US FDA approved atezolizumab + chemotherapy for adjuvant treatment of stage III dMMR Colon Cancer Perspective therapeutics receives US FDA Fast Track Designation for [212Pb]PSV359 in Solitary Fibrous Tumors US FDA granted Fast Track Designation to VIR-5500 in mCRPC China NMPA approves Enhertu as adjuvant therapy for HER2-positive early breast cancer and Datroway for metastatic TNBC US FDA approved atezolizumab + chemotherapy for adjuvant treatment of stage III dMMR

07/10/2026 US FDA grants two breakthrough therapy designations to AbbVie’s c-Met ADC Temab-A in CRC and NSCLC US FDA approves tucatinib-based maintenance regimen for HER2-positive Breast Cancer US FDA grants two breakthrough therapy designations to AbbVie’s c-Met ADC Temab-A in CRC and NSCLC (Ref) AbbVie announced that the US FDA has granted two Breakthrough Therapy Designations (BTDs) to c-Met-targeted antibody-drug conjugate (ADC), telisotuzumab adizutecan (Temab-A/ABBV-400

06/10/2026 Firmonertinib failed to demonstrate statistically significant PFS benefit in 1L EGFR Exon 20ins NSCLC Firmonertinib failed to demonstrate statistically significant PFS benefit in 1L EGFR Exon 20ins NSCLC (Ref) ArriVent announced a program update from the Phase 3 FURVENT trial evaluating firmonertinib (EGFR-TKI) as first-line treatment for patients with EGFR exon 20 insertion-mutant NSCLC. While the study did not meet its primary endpoint of progression-free surviva

05/10/2026 In Phase 3 EPCORE DLBCL-2 study, epcoritamab + R-CHOP significantly improved PFS in newly diagnosed DLBCL In Phase 3 EPCORE DLBCL-2 study, epcoritamab + R-CHOP significantly improved PFS in newly diagnosed DLBCL (Ref) Genmab and AbbVie reported positive Phase 3 EPCORE DLBCL-2 results, evaluating fixed treatment duration epcoritamab (T-cell engaging bispecific antibody) in combination with standard of care rituximab, cyclophosphamide, doxorubicin hydrochloride, vinc

02/10/2026 US FDA approves Jaypirca for treatment of previously untreated CLL/SLL patients US FDA approves Jaypirca for treatment of previously untreated CLL/SLL patients (Ref) Eli Lilly announced that the US FDA has approved Jaypirca (pirtobrutinib; BTK inhibitor) for adults with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who do not have a known 17p deletion, expanding the drug's use into the first-line setting The approval is supp

01/10/2026 Cullinan Initiates NDA Submission for Zipalertinib + Chemotherapy in 1L EGFR Exon 20ins NSCLC Trethera receives FDA Fast Track Designation for TRE-515 combination strategy in KRAS G12C-Mutant NSCLC Replimune announces US launch of TUDRIQEV™ for advanced Melanoma Cullinan Initiates NDA Submission for Zipalertinib + Chemotherapy in 1L EGFR Exon 20ins NSCLC (Ref) Cullinan Therapeutics announced the initiation of a US FDA New Drug Application (NDA) submission under the

30/09/2026 Atara Bio's partner Pierre Fabre Pharma, resubmits tab-cel BLA to FDA for EBV+ PTLD Celcuity Announces US Commercial Launch of REVTORPYK (gedatolisib) Atara Bio's partner Pierre Fabre Pharma, resubmits tab-cel BLA to FDA for EBV+ PTLD (Ref) Atara Biotherapeutics announced that its partner, Pierre Fabre Pharmaceuticals, has resubmitted the Biologics License Application (BLA) for tabelecleucel (tab-cel; allogeneic, off-the-shelf Epstein-Barr virus (EBV)-specific cyto

September 3rd Week, 2026 Regulatory Events 🎯 AstraZeneca’s sBLA for perioperative durvalumab (Imfinzi; anti-PD-L1) + Astellas Pharma and Pfizer’s neoadjuvant enfortumab vedotin (Padcev; Nectin-4 ADC) was accepted and granted Priority Review by the US FDA for the Tx of MIBC patients who are ineligible/have declined cisplatin-based chemotherapy (Ref1) ❓ What are the current efficacy benchmarks for perioperative MIBC? 🎯 The US FDA approved Merck&Co/MSD's belzutifan (Welir

29/09/2026 Plinabulin secures US FDA Fast Track Designation as BeyondSpring advances Phase 3 DUBLIN-4 NSCLC program with strategic China funding agreement HUTCHMED announces US NDA Submission for ORPATHYS + TAGRISSO in MET-Driven EGFR-Mutated NSCLC US FDA grants Orphan Drug and Rare Pediatric Disease designations to UTR Therapeutics' MYCN-targeting candidate UTRxMYCN M1-14 Plinabulin secures US FDA Fast Track Designation as BeyondSpring advances Phase 3 DUBLIN-4 NSCLC program

28/09/2026 Evorpacept demonstrates efficacy benefit in HER2-retained/high-CD47 gastric cancer subsets, in Phase 2 ASPEN-06 study; ALX will not pursue a US registrational Phase 3 study, evaluates partnership opportunities Innovent expands Phase 3 MarsLight-11 trial of IBI363/TAK-928 in NSCLC AstraZeneca invests $2B in Summit Therapeutics to advance ivonescimab-ADC combination strategy across multiple cancers Teva Receives US FDA Approval for DEGEVMA, a biosimilar to Xgeva (den

27/09/2026 Aumseqa EU Authorization Revoked Following Regulatory Challenge; Hansoh Pursues Refiling Aumseqa EU Authorization Revoked Following Regulatory Challenge; Hansoh Pursues Refiling (Ref) Hansoh Pharma announced that the European Commission has revoked the EU marketing authorization for lung cancer drug Aumseqa (aumolertinib mesylate tablets; EGFR-TKI) Decision stems from a regulatory procedural issue related to EU data protection requirements and is not associated wit

25/09/2026 In Phase 3 EXCALIBER-RRMM trial, ZENBEXUS™-based therapy significantly improved response depth and MRD-negative CR versus DVd in RRMM In Phase 2 CARTITUDE-2 study, single CARVYKTI infusion delivered 5-year treatment-free remission in 50% of early-line RRMM patients US FDA granted priority review for imfinzi + enfortumab vedotin in cisplatin-ineligible MIBC MSD and Daiichi Sankyo have voluntarily withdrawn the US BLA for I-DXd in previously treated ES-SCLC In Phase

24/09/2026 US FDA approves belzutifan + lenvatinib in post-IO advanced ccRCC based on PFS superiority over cabozantinib, despite no statistically significant OS benefit CSPC reports positive Phase III results for becotatug + osimertinib, demonstrating significant PFS benefit and favorable OS trend in first-Line EGFR Exon20ins NSCLC US FDA approves belzutifan + lenvatinib in post-IO advanced ccRCC based on PFS superiority over cabozantinib, despite no statistically significant

23/09/2026 US FDA approves LYRFIGTU™ (lirafugratinib) in FGFR2-Altered Cholangiocarcinoma SOTIO Advances SOT106 with Additional FDA Designations in Sarcoma In Phase 3 MajesTEC-3 study, TECVAYLI + DARZALEX FASPRO demonstrates durable survival outcomes and substantial progression risk reduction in RRMM US FDA approves LYRFIGTU™ (lirafugratinib) in FGFR2-Altered Cholangiocarcinoma (Ref) Elevar Therapeutics announced US FDA approval of LYRFIGTU™ (lirafugratinib), an irreversible

22/09/2026 US FDA requests additional OS evidence for Tovecimig in Biliary tract cancer despite positive COMPANION-002 efficacy results US FDA Conditionally Accepts LYRFIGTU™ Brand Name for Lirafugratinib US FDA requests additional OS evidence for Tovecimig in Biliary tract cancer despite positive COMPANION-002 efficacy results (Ref) Compass Therapeutics provides regulatory update on feedback received from the US FDA regarding Tovecimig (DLL4 × VEGF-A bispecific antibody) for