The U.S. FDA granted accelerated approval to Amgen Inc.’s Imdelltra (tarlatamab) for treating adults with extensive-stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy. The approval may well lead the drug to blockbuster status while bolstering the company’s cancer portfolio.
The Surveillance Heartcare Outcomes Registry trial demonstrated that Caredx Inc.’s Heartcare test identifies acute cellular rejection in heart transplant patients better than donor-derived cell-free DNA (dd-cfDNA) alone, while reducing biopsies and improving clinical outcomes. Heartcare combines two non-invasive tests, dd-cfDNA and Allomap Heart gene-expression profiling.
Shouyao Holdings (Beijing) Co. Ltd. has patented inhibitors of fibroblast growth factor receptor (FGFR), particularly FGFR2 and/or FGFR3, described as potentially useful for the treatment of cancer.
Shanghai Leadingtac Pharmaceutical Co. Ltd. has divulged proteolysis targeting chimera (PROTACs) compounds comprising an E3 ubiquitin ligase binding moiety covalently linked to a son of sevenless homolog 1 (SOS1) targeting moiety reported to be useful for the treatment of cancer, neurofibromatosis type 1, Costello syndrome, cardiofaciocutaneous syndrome and Noonan syndrome.
Even though HER3 is validated as a promising therapeutic target for cancer therapy, no HER3-targeting antibodies or antibody-drug conjugates (ADCs) have been approved for clinical use. Investigators at Duality Biologics (Suzhou) Co. Ltd. have developed DB-1310, a new HER3-targeting ADC being studied for the treatment of solid tumors, and published findings from preclinical characterization.
HERV-H LTR-associating protein 2 (HHLA2) is known to play immunosuppressive roles by interacting with killer cell immunoglobulin-like receptor 3DL3 (KIR3DL3). The expression of HHLA2 in cancer is associated with poor patient outcomes, making it a promising therapeutic target for immunotherapy. Nextpoint Therapeutics Inc. has presented data on their monoclonal antibodies NPX-267 and NPX-887, which target KIR3DL3 and HHLA2, respectively.
Following a cumbersome process, the U.S. FDA is withdrawing its accelerated approval for Truseltiq (infigratinib) as a second-line treatment for patients with unresectable locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test.
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
RSS
