Merck's Keytruda approved for cancer patients with certain genetic traits | Genmab/Janssen to launch 3 studies for multiple myeloma drug Darzalex | US FDA approves memantine HCl tablets from Strides Shasun
May 25, 2017
News on diagnostic and therapeutic innovations and regulatory science
The FDA has granted accelerated approval to Merck's Keytruda, or pembrolizumab, as a treatment for patients with solid tumor cancer who have the microsatellite instability-high biomarker or mismatch repair deficient, and who are not eligible for surgery. The decision marks the first approval of a cancer drug based on genetic traits.
Three clinical trials will be launched between July 2017 and early 2018 in a joint venture between Genmab and Janssen Biotech to test the efficacy of Janssen's drug Darzalex, or daratumumab, in patients with multiple myeloma. The planned trials -- two Phase III and one Phase II -- "emphasize the commitment to test daratumumab broadly in many different clinical settings, which hopefully results in better treatment options for patients," said Genmab CEO Jan van de Winkel.
India-based Strides Shasun has been given approval by the US FDA for its memantine hydrochloride tablets USP, 5 mg and 10 mg, for the treatment of moderate to severe Alzheimer-type dementia. The company's facility in Bengaluru, India, will produce the drug, while Strides Pharma will commercialize it in the US.
Aurobindo Pharma's generic amlodipine and olmesartan medoxomil tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg, have been approved by the US FDA as a treatment for patients with hypertension as the generic equivalent to the reference drug, Daiichi Sankyo's Azor. Aurobindo's Glipizide extended-release tablets, 2.5 mg, 5 mg and 10 mg, were also granted FDA approval for diabetes indication as a generic equivalent to Pfizer's Glucotrol XL.
US-China oncology firm Xynomic Pharma is teaming up with the University of California at San Francisco on a Phase II/III clinical trial of its leading drug, abexinostat, an HDAC inhibitor used to fight chemotherapy resistance that has been tested globally in 17 early- and midstage trials. The study will build on positive clinical data from a new UCSF Phase Ib clinical trial sponsored by the National Cancer Institute.
WuXi App Tec subsidiary STA Pharmaceutical, the Shanghai Municipal FDA and the Jinshan government will co-host a summit focusing on China's recently initiated Marketing Authorization Holder pilot program on June 22 in Shanghai. The program permits license holders to sell pharmaceuticals in China through contract manufacturers, speeding time to market and enhancing local innovation.
An FDA committee determined that the biosimilar developed by Hospira is close enough to Amgen's anemia drug Epogen and could gain approval after an upcoming panel review. Regulators rejected the initial filing for the biosimilar made in 2015.
The FDA has granted breakthrough therapy designation to Achaogen's antibiotic plazomicin, intended to treat serious bacterial infections caused by multidrug-resistant Enterobacteriaceae and carbapenem-resistant Enterobacteriaceae. Achaogen plans to file a new-drug application to the agency in the second half of this year.
Sanofi and Regeneron Pharmaceuticals' Kevzara, or sarilumab, has been approved by the FDA for the treatment of adult patients with moderate to severe rheumatoid arthritis. The companies anticipate European approval of Kevzara in the next few months.