Daily Top News – June 22, 2020

June 22, 2020

Xpovio (selinexor) / Ono Pharma, Karyopharm, Antengene
Karyopharm announces FDA approval of Xpovio (selinexor) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (GlobeNewswire) – Jun 22, 2020 – “Karyopharm Therapeutics…announced that the U.S. Food and Drug Administration (FDA) has approved oral XPOVIO® (selinexor)…for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy….XPOVIO will be commercially available immediately in this new indication in the U.S. and Karyopharm will leverage its existing commercial infrastructure to market this second oncology indication. A Marketing Authorization Application for selinexor for relapsed or refractory DLBCL is planned for submission to the European Medicines Agency in 2021.”

 

Relumina (relugolix) / Gedeon Richter, Roivant, Takeda, ASKA Pharma
Myovant Sciences Announces Priority Review and FDA Acceptance of New Drug Application for Once-Daily, Oral Relugolix for Advanced Prostate Cancer (GlobeNewswire) – Jun 22, 2020 – “Myovant Sciences…announced that its New Drug Application (NDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA)…The FDA has set a target action date of December 20, 2020 under the Prescription Drug User Fee Act (PDUFA)….Data from an additional key secondary endpoint, castration resistance-free survival, are expected in the third quarter of 2020.”

 

Keytruda (pembrolizumab) / Merck (MSD)
Merck’s Keytruda (pembrolizumab) approved in China for second-line treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (CPS ≥10) (Merck (MSD) Press Release) – Jun 22, 2020 – “Merck…announced that KEYTRUDA…has been approved by the National Medical Products Administration (NMPA) in China as monotherapy for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by a fully validated test, following failure of one prior line of systemic therapy. This new indication was granted full approval based on the overall survival (OS) findings from the global Phase 3 KEYNOTE-181 trial, including data from an extension of the global study in Chinese patients.”

 

 

Qinlock (ripretinib) / Deciphera
Deciphera announces Health Canada’s authorization of Qinlock (ripretinib) for the treatment of fourth-line gastrointestinal stromal tumor (Businesswire) – Jun 22, 2020 – “Deciphera Pharmaceuticals…announced that Health Canada has authorized QINLOCK™ (ripretinib)…for sale in Canada for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib. The QINLOCK New Drug Submission was approved by Health Canada under Project Orbis, an initiative of the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence designed to provide a framework for concurrent submission and review of oncology products among international partners….Health Canada’s authorization was based on efficacy results from the pivotal Phase 3 INVICTUS study of QINLOCK in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK.”

 

Bavencio (avelumab) / EMD Serono, Pfizer
European Medicines Agency Validates Application for BAVENCIO (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma (Merck (MSD) Press Release) – Jun 22, 2020 – “Merck and Pfizer Inc….today announced that the European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO® (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). With this validation, the application is complete, and the EMA will now begin the review procedure. The application is based on results from the Phase III JAVELIN Bladder 100 study…The data were presented at the ASCO 2020 Virtual Scientific Meeting.”

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