“The FDA granted priority review to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with pemetrexed and platinum chemotherapy for the treatment of patients with newly diagnosed metastatic nonsquamous non-small cell lung cancer.
“Pembrolizumab (Keytruda, Merck) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.”
“The FDA has granted a priority review to a supplemental biologics license application (sBLA) for Opdivo (nivolumab) for the treatment of patients with small cell lung cancer (SCLC) with disease progression following two or more lines of therapy, according to Bristol-Myers Squibb, the manufacturer of the PD-1 inhibitor.
“The sBLA is based on data from the phase 1/2 CheckMate-032 trial, in which single-agent Opdivo led to a median overall survival (OS) of 4.4 months and a one-year OS rate of 33 percent in patients with progressive SCLC following one or more prior lines of therapy. Under the priority review, the FDA is scheduled to make its decision by Aug. 16, 2018.”
“At first glance, a bill passed by the House of Representatives this week seems like the kind of thing anyone could get behind.
“Known as the “Right to Try” legislation, it would allow terminally ill patients access to experimental drugs without the approval of the Food and Drug Administration.
“But the bill and a similar one passed last summer by the Senate do little to address the main barrier that patients face in getting unapproved treatments: permission from the drug companies themselves.”
“The Food and Drug Administration granted Xtandi (enzalutamide) a priority review to a supplemental new drug application for the treatment of patients with nonmetastatic castration-resistant prostate cancer, according to the companies developing the drug, Pfizer and Astellas.
“The sNDA is based on data from the phase 3 PROSPER trial in which the combination of Xtandi and androgen deprivation therapy (ADT) reduced the risk of metastases or death by 71 percent compared with ADT alone for patients with nonmetastatic CRPC. In the double-blind study, the median metastasis-free survival (MFS) was 36.6 months with Xtandi plus ADT versus 14.7 months with ADT alone.”
“The FDA authorized marketing the direct-to-consumer Personal Genome Service Genetic Health Risk Report for three mutations of BRCA1 and BRCA2 most common among people of Eastern European Ashkenazi Jewish descent, according to a press release.
“The test — marketed by 23andMe — analyzes DNA using self-collected saliva samples to determine whether a woman is at increased risk for breast and ovarian cancer and whether a man is at increased risk for breast or prostate cancer.”
“Findings from the phase III NETTER-1 trial led to the January 2018 FDA approval of Lutathera (lutetium Lu 177 dotatate) for the treatment of patients with somatostatin receptor–positive gastroenteropancreatic tumors (GEP-NETs). The trial compared Lutathera with high-dose octreotide LAR for patients with 1 or 2 metastatic midgut NETs.
“In NETTER-1, patients with midgut NETs who progressed on 30 mg of octreotide were randomized to Lutathera (n = 116) or high-dose octreotide (n = 113). Patients received 4 doses of Lutathera at 7.4 GBq every 8 weeks in combination with 30 mg of octreotide. The control arm received 60 mg of octreotide LAR every 4 weeks.”
“The U.S. Food and Drug Administration has given another approval for a breast cancer treatment developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The announcement marks the third FDA approval for Verzenio in five months.
“The most recent ruling approves Verzenio, also known as abemaciclib, for use in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of postmenopausal women with advanced or metastatic breast cancer. Lilly says the approval follows the results of a successful Phase 3 clinical trial.”
“The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).”
“The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.”