The U.S. Food and Drug Administration approved Truseltiq (infigratinib) under the accelerated approval program for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement.
Merck presented new data from the Phase III CLEAR trial (KEYNOTE-581/Study 307) at the virtual 2021 Genitourinary Cancers Symposium of the company’s checkpoint inhibitor Keytruda (pembrolizumab) and Eisai’s tyrosine kinase inhibitor Lenvima (lenvatinib) in renal cell carcinoma.
A roundup of biopharma news and updates includes Merck and Eisai’s Keytruda-Lenvima combo hitting the mark in a Phase III study for advanced endometrial cancer.
Merck and Eisai announced new investigational data demonstrating positive top-line results from the Phase III KEYNOTE-581/CLEAR trial (Study 307).
AstraZeneca and Daiichi Sankyo’s Enhertu received supplemental Biologics License Application (sBLA) acceptance and U.S. priority review for the treatment of HER2-positive metastatic gastric cancer.
Amgen presented positive topline data from the Phase II CodebreaK 100 trial of sotorasib in KRAS G12C-mutant advanced non-small cell lung cancer (NSCLC).
Bristol Myers Squibb announced that the Phase III IDHENTIFY trial of Idhifa (enasidenib) plus best supportive care compared to conventional care did not meet the primary endpoint of overall survival in relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation.
The U.S. Food and Drug Administration approved MorphoSys and Incyte’s Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
Wilmington, Delaware-based Incyte Corporation announced data from the Phase III REACH3 trial of Jakafi (ruxolitinib) in patients with moderate or severe steroid-refractory or steroid dependent chronic graft-versus-host disease (GVHD).
The U.S. Food and Drug Administration approved Jazz Pharmaceuticals and company partner PharmaMar’s Zepzelca (lurbinectedin) for adults with metastatic small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy.