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THOUSAND OAKS, Calif., Feb. 16, 2021 /PRNewswire/ Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with
KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy.
The FDA grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for sotorasib is Aug. 16, 2021, which is four months earlier than the standard review cycle.
Karyopharm Reports Fourth Quarter and Full Year 2020 Financial Results and Highlights Recent Company Progress Commercial Launch of XPOVIO® (selinexor) In Expanded Multiple Myeloma Indication Fully Underway Following December 18, 2020 FDA Approval XPOVIO Net Product Sales of $20.2 Million for Fourth Quarter 2020 and $76.2 Million for the Year 2020; Total Revenues of $35.1 Million for the Fourth Quarter 2020 and $108.1 Million for the Year 2020 Positive CHMP Opinion for NEXPOVIO® (selinexor) in Penta-Refractory Multiple Myeloma Issued; European Commission Decision Expected by April 2021 Conference Call Scheduled for Today at 8:30 a.m. ET
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Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Myovant Sciences Announces Corporate Updates and Financial Results for Third Quarter of Fiscal .
Myovant Sciences, Inc.February 11, 2021 GMT
ORGOVYX™ (relugolix) approved by the
U.S. Food and Drug Administration (FDA) in December 2020 as the first and only oral GnRH receptor antagonist for adult patients with advanced prostate cancer; ORGOVYX launched in the U.S. in early January 2021
Announced collaboration with Pfizer in December 2020 to jointly develop and commercialize relugolix in oncology and relugolix combination tablet in women’s health in the U.S. and Canada
Global biopharmaceutical company Bristol Myers Squibb (BMS) has received US Food and Drug Administration (USFDA) approval for its new CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel).
Breyanzi demonstrated a 73% overall response rate and 54% complete response rate in the largest pivotal trial in 3L+ LBCL, TRANSCEND NHL 001 trial Breyanzi demonstrated sustained responses in patients who achieved a CR with median duration of response not reached G rade ≥3 cytokine release syndrome and Grade ≥3 neurologic toxicities following Breyanzi treatment occurred in 4% and 12% of patients, respectively .