The FDA has granted accelerated approval to Retevmo™ (selpercatinib; Lilly).
The Food and Drug Administration has granted accelerated approval to Tabrecta™ (capmatinib; Novartis).
Trodelvy is the first antibody-drug conjugate to get FDA approval for this indication.
Sanofi and Regeneron announced that the phase 3 trial evaluating cemiplimab (Libtayo®) as a potential first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer was stopped early due to “highly significant improvement” in overall survival.
Pemigatinib, a small molecule kinase inhibitor, selectively targets FGFR isoforms 1, 2 and 3, which, in preclinical studies, has resulted in anti-tumor activity in cells with FGFR alterations.
The FDA has approved the supplemental New Drug Application for Imbruvica® (ibrutinib;Janssen) in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Ontruzant is supplied in 150 mg single-dose vials and 420 mg multidose vials.
The application is supported by data from 2 pivotal open-label, randomized phase 3 trials (SIOPEL 6 and ACCL0431), which compared the efficacy of sodium thiosulfate plus cisplatin to cisplatin alone for the prevention of cisplatin-induced hearing loss.
Approval was based on data from the ongoing open-label, single-arm, phase 3 OLYMPUS study.
Results demonstrated that nivolumab plus ipilimumab met the primary end point of superior overall survival at a prespecified interim analysis vs chemotherapy alone.
