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

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

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

11/11/2025 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

01/09/2025 Boehringer’s zongertinib received accelerated approval in China for HER2-mutant advanced NSCLC ( Ref ) China’s National...

28/08/2025 TOLREMO Therapeutics' TT125-802 received two fast track designations from the US FDA for NSCLC (Ref) The US FDA granted two fast track designations to TOLREMO Therapeutics' TT125-802 (CBP/p300 inhibitor) for the treatment of NSCLC: For the treatment of patients with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 L858R substitution mutation, with disease progression on at least one line of prior therapy including an EGFR inhibitor For

25/08/2025 Quest Diagnostics' Haystack MRD® test received the Breakthrough Device Designation from the FDA for colorectal cancer (Ref) The US FDA granted the Breakthrough Device Designation for Quest Diagnostics' Haystack MRD® test for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling. Dan Edelstein, Vice President and General Mana

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

08/08/2025 Boehringer Ingelheim's Hernexeos received accelerated approval from the US FDA for HER2-mutant advanced NSCLC (Ref) The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (Hernexeos; kinase inhibitor) for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. The approval is based on data from the Phase 1b Bea

05/08/2025 Immutep received positive feedback from the FDA for the late-stage development of Eftilagimod Alfa in SCCHN (Ref) Immutep received positive and constructive feedback from the US FDA regarding future clinical development of eftilagimod alpha (soluble LAG-3 protein) as a first-line Tx of R/M SCCHN with PD-L1 CPS <1. Based on available data from cohort B of the Ph2b TACTI-003 trial of efti + pembro in R/M SCCHN with CPS <1, the FDA agreed on the potential of the comb

04/08/2025 Alphamab's IND application for JSKN022 was accepted by China's CDE (Ref) Alphamab Oncology's IND application for JSKN022 (PD-L1 x integrin αvβ6 bispecific antibody-drug conjugate) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The company plans to initiate a first-in-human trial of JSKN022 for the treatment of advanced malignant solid tumors The Ph1 trial will evaluate the safety, tolerability, PK/P

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