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 granted

16/12/2025 Adagene's muzastotug + pembro received the FDA fast track designation for MSS mCRC without current or active liver metastases Adagene's muzastotug + pembro received the FDA fast track designation for MSS mCRC without current or active liver metastases (Ref) The US FDA granted the fast track designation (FTD) to Adagene's muzastotug (ADG126; masked anti-CTLA-4) + pembrolizumab for the treatment of adult patients with microsatellite stable metastatic colorectal cance

15/12/2025 Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan + pertuzumab has been approved for first-line HER2+ve breast cancer FibroGen's roxadustat received the FDA Orphan Drug Designation for myelodysplastic syndromes Eli Lilly's TECVAYLI plus DARZALEX FASPRO combo has been selected for the FDA's CNPV Pilot program Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan + pertuzumab has been approved for first-line HER2+ve breast cancer (Ref) The US FDA granted appr

12/12/2025 Arcus and Gilead have discontinued the Phase 3 STAR-221 trial of their TIGIT regimen in gastric and esophageal cancers Johnson & Johnson's AKEEGA received FDA approval for BRCA2-mutated CSPC Arcus and Gilead have discontinued the Phase 3 STAR-221 trial of their TIGIT regimen in gastric and esophageal cancers (Ref) The Phase 3 STAR-221 trial of Arcus Biosciences and Gilead's domvanalimab (anti-TIGIT) + zimberelimab (anti-PD-1) + chemotherapy vs nivolumab + chemother

09/12/2025 Senti Biosciences' SENTI-202 received the FDA's RMAT designation for hematologic malignancies Zydus and Formycon enter into an exclusive partnership for the Keytruda biosimilar, FYB206 Senti Biosciences' SENTI-202 received the FDA's RMAT designation for hematologic malignancies (Ref) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Senti Biosciences' SENTI-202 (logic gated off-the-shelf CAR-NK cell therapy) for the treatment of re

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

04/12/2025 BMS' Breyanzi received FDA approval for R/R MZL J & D Pharmaceuticals' investigational therapy received the FDA orphan drug designation for HCC BMS' Breyanzi received FDA approval for R/R MZL (Ref) The US FDA granted approval to Bristol Myers Squibb's lisocabtagene maraleucel (Breyanzi; CD19-directed CAR-T cell therapy) for the treatment of adult patients with R/R marginal zone lymphoma who have received at least two prior lines of systemic therapy. The approval

03/12/2025 Eli Lilly and Company's pirtobrutinib received the FDA approval for R/R CLL/SLL Eli Lilly and Company's pirtobrutinib received the FDA approval for R/R CLL/SLL (Ref) The US FDA granted approval to Eli Lilly and Company's pirtobrutinib (Jaypirca; BTK inhibitor) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. This approval conve

21/11/2025 Pembrolizumab + enfortumab vedotin received the FDA approval for MIBC (Ref) The US FDA granted approval to Merck & Co./MSD pembrolizumab (anti-PD-1; both IV and SC formulations) in combination with Pfizer and Astellas' enfortumab vedotin (Nectin-4 ADC) as a neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy

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 pharmacok

18/11/2025 AbbVie and Genmab's epcoritamab + rituximab + lenalidomide received FDA approval for R/R FL (Ref) The US FDA granted approval to AbbVie and Genmab's epcoritamab (bispecific CD20-directed CD3 T-cell engager) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the Phase 3 EPCORE FL-1 trial of the combo vs rituximab and lenalidomide Lorenzo Falchi, M.D., Ly

13/11/2025 Kura Oncology and Kyowa Kirin's ziftomenib received FDA approval for certain R/R AML pts (Ref) The US FDA granted full approval to Kura Oncology and Kyowa Kirin's ziftomenib (KOMZIFTI™; menin inhibitor) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Troy Wilson, President and CEO, Kura Oncology: “KOMZIFTI combines compelling efficacy, a favor

11/11/2025 Allterum Therapeutics' 4A10 received the FDA fast track designation for ALL (Ref) The US FDA granted the fast track designation to Allterum Therapeutics' 4A10 (anti-IL-7Rα) for the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL). Yan Moore, CEO, Allterum Therapeutics: "The FDA's Fast Track designation for 4A10 affirms its potential and empowers us to work hand-in-hand with the agency to bring this therapy to patients and familie

06/11/2025 Johnson & Johnson's Darzalex Faspro has been approved by the FDA for HR-SMM (Ref) The US FDA approved Johnson & Johnson's Darzalex Faspro® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). The approval is based on results from the Ph3 AQUILA/NCT03301220 trial, which evaluated the efficacy and safety of Darzalex Faspro vs active monitoring (or “Watch and Wait”) in patients with HR

08/10/2025 Regeneron's cemiplimab has been approved by the US FDA for the adjuvant Tx of CSCC (Ref) The US FDA approved Regeneron Pharmaceuticals' Libtayo® (cemiplimab; PD-1 inhibitor) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The approval is based on results from the pivotal Phase 3 C-POST trial of adjuvant Libtayo vs placebo in patients with CSCC at high risk of recurrenc

02/10/2025 Aminex Therapeutics' AMXT 1501 + DFMO received the FDA Orphan Drug Designation for Neuroblastoma (Ref) The US FDA granted the Orphan Drug Designation to Aminex Therapeutics' AMXT 1501 (polyamine transport inhibitor) + difluoromethylornithine for the treatment of patients with neuroblastoma. Mark Burns, CSO and President, Aminex Therapeutics: "Receiving Orphan Drug Designation for AMXT 1501 in combination with DFMO represents an important milestone in our mission to

30/09/2025 Umoja Biopharma's UB-VV111 in vivo CAR T cell therapy received the FDA fast track designation for B-Cell Malignancies (Ref) The US FDA granted the fast track designation to Umoja Biopharma's UB-VV111 (off-the-shelf drug product that generates CD19-directed CAR T cells in vivo) for the treatment of relapsed/refractory Large B-cell Lymphoma following two or more lines of prior therapy and relapsed/refractory Chronic Lymphocytic Leukemia following two or more lines of

25/09/2025 Eli Lilly and Company's Inluriyo has been approved in the US for ER+, HER2–, ESR1-mutated breast cancer (Ref) The US FDA approved Eli Lilly and Company's Inluriyo (imlunestrant, oral estrogen receptor antagonist) for the treatment of adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. The FDA approval is based on the results of the Phase 3 EMBER-3 trial Inluriyo reduced the

17/09/2025 Rgenta Therapeutics' RGT-61159 received the FDA Orphan Drug Designation for ACC (Ref) The US FDA granted the Orphan Drug Designation to Rgenta Therapeutics' RGT-61159 (small molecule inhibitor of MYB) for the treatment of adenoid cystic carcinoma (ACC). The asset is currently being evaluated in a Phase 1a/b clinical trial in patients with advanced relapsed or refractory ACC or colorectal cancer Travis Wager, Co-founder and CSO, Rgenta: “Granting of ODD by the FDA h

09/09/2025 Johnson & Johnson's INLEXZO received US FDA approval for NMIBC (Ref) The US FDA approved Johnson & Johnson's INLEXZO™ (TAR-200; gemcitabine intravesical system) for the treatment of adult patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The approval is based on results from the Phase 2b SunRISe-1/NCT04640623 trial Jennifer Taubert, Executive Vice President, Worldwide Chairman,