Nanatinostat Gets Orphan Drug Designation for EBV-Associated Cancers
The “Kick & Kill” platform is designed to treat viral-associated cancers and other serious diseases.
The “Kick & Kill” platform is designed to treat viral-associated cancers and other serious diseases.
Merck announced that the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
The approval was supported by data from a phase 2 multicenter, open-label, single-arm trial (N=87) of patients with locally advanced or metastatic bladder cancer with FGFR3 or FGFR2 genetic alterations that had progressed following treatment with chemotherapy.
The Food and Drug Administration (FDA) has placed a partial hold on all clinical trials evaluating venetoclax (Venclexta; AbbVie and Genentech) for the treatment of multiple myeloma. This was prompted after a review of data from the phase 3 BELLINI trial (M14-031) showed a higher proportion of deaths in the venetoclax treatment arm compared with…