Abbisko Therapeutics Co. Ltd. has out-licensed China rights to its colony-stimulating factor 1 receptor inhibitor, pimicotinib, to Merck KGaA in a deal worth up to $605.5 million. Pimicotinib is in phase III trials in patients with tenosynovial giant cell tumors in China, the U.S., Canada and Europe.
The U.S. FDA’s advisory hearing on multi-cancer detection (MCD) tests suggests that the premarket requirements for these tests will be rigorous, if only because the agency stated at the outset of the hearing that it sees these tests as class III devices. However, the advisory committee also suggested that a registry be established to track outcomes for these tests, a requirement that is likely to prove expensive and time-consuming to fulfill.
Simcere Pharmaceutical Group Ltd.’s subsidiary Simcere Zaiming Pharmaceutical Co. Ltd. has received FDA clearance of an IND application for SIM-0501, an oral small-molecule inhibitor of ubiquitin-specific peptidase 1 (USP1), for advanced solid tumors.
Voronoi and Voronoi Bio Inc. have patented heteroaryl derivative compounds acting as serine/threonine-protein kinase B-raf (BRAF) inhibitors and reported to be useful for the treatment of cancer.
Phosphatidylinositol 3-kinase α (PI3Kα) (H1047R mutant) inhibitors are described in a Relay Therapeutics Inc. patent as potentially useful for the treatment of cancer, particularly, breast and ovarian cancer.
Eli Lilly and Co., through its Loxo@Lilly oncology unit, secured its second accelerated approval for non-covalent Bruton’s tyrosine kinase (BTK) inhibitor Jaypirca (pirtobrutinib), this time to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. The U.S. FDA approval of 100-mg and 50-mg tablets is for patients who have received two prior lines of therapy, including another BTK inhibitor and a BCL-2 inhibitor. It is based on phase I/II data from a subset of 108 patients participating in the open-label, single-arm, multi-cohort Bruin trial.
Using minimally invasive focal therapies to treat prostate cancer are much more cost-effective and can improve patients’ quality of life compared to surgery or radiotherapy, according to a study published in the Journal of Medical Economics.
An F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. patent describes indole derivatives acting as EGFR L858R mutant, T790M/L858R double mutant, T790M/L858R/C797S triple mutant and/or L858R/C797S double mutant allosteric inhibitors reported to be useful for the treatment of non-small-cell lung cancer (NSCLC).
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