FDA approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
The University of Texas MD Anderson Cancer Center and AmMax Bio, Inc. announced a worldwide exclusive license agreement and clinical trial agreement to develop and advance AmMax’s AMB-066 monoclonal antibody therapy as a first-in-class treatment option for patients with colorectal cancer and minimal residual disease as well as those with MRD in other solid tumors.
PolyPid Ltd. announced a new research and development collaboration with ImmunoGenesis Inc. The collaboration focuses on the development of novel formulations utilizing PolyPid’s experience with its proprietary PLEX Technology and ImmunoGenesis’ potent STimulator of INterferon Genes agonist drug candidate to potentially enhance treatment for solid tumors.
Dewpoint Therapeutics and ConcertAI announced the first phase of their Translational Oncology partnership, aligned around Dewpoint’s latest drug candidate, DPTX3186.
FDA has granted accelerated approval to zenocutuzumab-zbco (Bizengri) for adults
Merus a clinical-stage oncology company developing innovative, full-length multispecific antibodies and Partner Therapeutics Inc., a private, fully-integrated biotechnology company with a focus in hematology and oncology, announced they have entered into an agreement in which Merus has exclusively licensed to PTx the right to commercialize zenocutuzumab (Zeno, also called Bizengri) for the treatment of NRG1 fusion-positive cancer in the U.S.
ConcertAI announced a joint software-as-a-service solution in hematological malignancies for research analytics, clinical trial design, and clinical trial operational optimization.
FDA recently approved Alternative Standard #25 related to the Mammography Quality Standards Act. Alternative Standard #25 allows the interpreting physician to provide an assessment of “Incomplete: Need additional imaging evaluation” for the follow-up report issued within 30 calendar days of an initial report that received an assessment of “Incomplete: Need prior mammograms for comparison.”
FDA approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.
FDA accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer, as detected by an FDA-approved test. Ziihera was approved under accelerated approval based on a 52% objective response rate and a median duration of response of 14.9 months as determined by independent central review. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The phase III HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.
