28/04/2026 FDA accepts NDA for zipalertinib in EGFR exon 20–mutated NSCLC; PDUFA set for Feb 2027 FDA Grants RMAT Designation to Orca-Q, Advancing Precision Cell Therapy for High-Risk Hematologic Malignancies Scancell’s iSCIB1+ secures FDA Fast Track with 77% PFS, Phase 3 initiation anticipated in H2 2026 for advanced Melanoma Henlius secures EU approval for POHERDY® (pertuzumab biosimilar), expanding global oncology footprint FDA accepts NDA for zipalertinib in EGFR exon 20–

07/04/2026 Corbus Gains FDA Alignment on CRB‑701 Registrational Trials in HNSCC and Cervical Cancer Nuvalent Submits NDA for Neladalkib in ALK+ NSCLC NextCure Receives Fast Track Designation for SIM0505 (CDH6 ADC) in Ovarian Cancer Corbus Gains FDA Alignment on CRB‑701 Registrational Trials in HNSCC and Cervical Cancer ( Ref ) Corbus reached broad agreement with the FDA on the registration path for CRB-701, a next-generation Nectin-4 targeting antibody-drug conjugate (ADC), i

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 pati

25/03/2026 Corcept's relacorilant + nab-paclitaxel received FDA approval for platinum-resistant Ovarian Cancer TRIANA Biomedicines' TRI-611 received the FDA fast track designation for ALK+ NSCLC In a $6.7B deal, Merck & Co acquired Terns Pharmaceuticals to expand its hematology pipeline Corcept's relacorilant + nab-paclitaxel received FDA approval for platinum-resistant Ovarian Cancer ( Ref ) The US FDA granted approval to Corcept Therapeutics Incorporated's Lifyorli (relaco

21/03/2026 Dizal's Phase 3 WU-KONG28 trial of ZEGFROVY met its PFS endpoint as a first-line treatment of EGFRexon20ins NSCLC Dizal's Phase 3 WU-KONG28 trial of ZEGFROVY met its PFS endpoint as a first-line treatment of EGFRexon20ins NSCLC ( Ref ) The multinational Phase 3 WU-KONG28 trial evaluating Dizal's ZEGFROVY® (sunvozertinib) monotherapy as first-line treatment in NSCLC with EGFR exon20ins met its primary endpoint of PFS. The WU-KONG28 study evaluated ZEGFROVY versus pl

March 2nd Week, 2026 Regulatory Events 🎯 The EC has approved an indication extension for Johnson & Johnson Innovative Medicine 's AKEEGA® (niraparib and abiraterone acetate dual action tablet) with prednisone or prednisolone in combination with androgen deprivation therapy, for the treatment of patients with metastatic hormone-sensitive prostate cancer and BRCA1/2 mutations (germline and/or somatic). (Ref 1) ❓ How do the outcomes of this regimen compare against the other ap

13/03/2026 Immutep's Phase 3 TACTI-004 trial of eftilagimod alfa regimen in 1L NSCLC NSCLC has been discontinued Immutep's Phase 3 TACTI-004 trial of eftilagimod alfa regimen in 1L NSCLC NSCLC has been discontinued ( Ref ) Based on the Independent Data Monitoring Committee (IDMC) recommendation, Immutep's Phase 3 TACTI-004 trial of eftilagimod alfa (LAG-3 MHC Class II agonist) + pembrolizumab + chemo regimen as a first-line treatment of NSCLC has been discontinued. Following

26/02/2026 Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC Izalontamab brengitecan elicited significant PFS and OS benefit in TNBC Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC ( Ref ) The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (kinase inhibitor) for an expanded indication for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mut

23/02/2026 Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer RYBREVANT SC received EC approval for Q3W and Q4W dosing for EGFR-mutated NSCLC Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer ( Ref ) The US FDA granted the Fast Track designation to Artios Pharma's ART6043 (DNA polymerase theta (Polθ) inhibitor) + olaparib (PARP inhibitor) for the treatment of adult patients with germline BRCA

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 Deci

16/02/2026 Phase 3 LIBRETTO-432 trial of adjuvant selpercatinib met the EFS endpoint in RET fusion positive NSCLC Phase 3 LIBRETTO-432 trial of adjuvant selpercatinib met the EFS endpoint in RET fusion positive NSCLC ( Ref ) Eli Lilly and Company announced positive topline results from the Phase 3 LIBRETTO-432 clinical trial of selpercatinib (Retevmo; RET kinase inhibitor) as an adjuvant therapy versus placebo in patients with early-stage (II-IIIA) RET fusion-positive NSCLC.

09/02/2026 Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC ( Ref ) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Krystal Biotec's KB707 (redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment) for the treatment of advanced

29/01/2026 Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia Summit's BLA for ivonescimab + chemo accepted by the FDA for EGFRm NSCLC The Phase III IMpower030 trial of perioperative atezolizumab + chemo failed to meet EFS endpoint in NSCLC Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia ( Ref ) The US FDA granted the Fast Track designation to Quetzal Therapeutics' QTX

08/01/2026 Revolution Medicines' zoldonrasib received the FDA breakthrough therapy designation for KRAS G12D-mutated NSCLC 858 Therapeutics' ETX-19477 received the FDA fast track designation for BRCA-mutated HGSOC Revolution Medicines' zoldonrasib received the FDA breakthrough therapy designation for KRAS G12D-mutated NSCLC ( Ref ) The US FDA granted the breakthrough therapy designation to Revolution Medicines' zoldonrasib (RAS(ON) G12D-selective inhibitor) for the treatment

06/01/2026 Cellenkos' CK0804 received the FDA orphan drug designation for myelofibrosis Bayer's sevabertinib received the breakthrough therapy designation for HER2-mutant NSCLC Cellenkos' CK0804 received the FDA orphan drug designation for myelofibrosis ( Ref ) The US FDA granted the orphan drug designation to Cellenkos' CK0804 (CXCR4hi Treg therapeutic) for treatment of myelofibrosis. Dr. Simrit Parmar, MD, Founder, Cellenkos: " Receiving Orphan Drug Designation is an import

17/12/2025 Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma J&J's RYBREVANT FASPRO™ received the FDA approval for the treatment of EGFR-mutated NSCLC pharmaand GmbH's Rubraca received the FDA full approval for the treatment of BRCA mutant mCRPC Perioperative pembro + enfortumab vedotin elicited significant benefit in MIBC Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma ( Ref ) The European Commission grant

December 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted approval to Johnson & Johnson Innovative Medicine 's sNDA for niraparib and abiraterone acetate dual-action tablet (PARB inhibition and novel hormonal therapy) + prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? Clinical Events 🔬 The Phase 3 STAR-221 trial o

25/11/2025 CStone Pharmaceuticals' sugemalimab received the EC approval for unresectable stage III NSCLC ( Ref ) The European Commission granted approval to CStone Pharmaceuticals' sugemalimab (anti-PD-L1) as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 ≥1% and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy. Dr. Jason Yang, CEO, President of R&D,

20/11/2025 Taiho and Cullinan initiated the rolling submission of a NDA for zipalertinib in EGFR-mutant NSCLC ( Ref ) Taiho and Cullinan Therapeutics have initiated the rolling submission of a NDA to the US FDA seeking accelerated approval of zipalertinib (EGFR tyrosine kinase inhibitor) for the treatment of patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations who have previously received platinum-based systemic chemotherapy. The submission is based

19/11/2025 Roche's Lunsumio SC received conditional approval in EU for R/R FL ( Ref ) The European Commission granted conditional marketing authorisation to Roche's mosunetuzumab (Lunsumio; CD20 x CD3 bispecific antibody) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The approval is based on results from the Phase I/II GO29781 trial in which Lunsumio SC had pharmac