As we end October and head into November, the Food and Drug Administration (FDA) continues its work. This upcoming week has several PDUFA action dates for drug applications. Here’s a look.
As we end October and head into November, the Food and Drug Administration (FDA) continues its work. This upcoming week has several PDUFA action dates for drug applications. Here’s a look.
Merck’s Keytruda in Combination for Lung Cancer
Merck has a PDUFA date of October 30 for a supplemental Biologics License Application (sBLA) for Keytruda, its anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. This was being reviewed under accelerated approval based on data from the Phase III KEYNOTE-407 clinical trial.
“Keytruda has already been established as an important treatment option for non-small cell lung cancer in the first-line setting, and with our broad development program in lung cancer, we are committed to improving survival for as many patients as we can,” stated Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
Trevena’s Olinvo for Moderate-to-Severe Acute Pain
Trevena’s Olinvo (oliceridine) for moderate-to-severe acute pain in adults has a target action date of November 2. On October 11, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) met to review the drug. The drug is a G-protein biased mu-opioid receptor (MOR) ligand for pain in settings where intravenous therapy is warranted. The Adcom voted 8 against and 7 in favor of the drug. The FDA isn’t obliged to follow the Adcom’s recommendation, although they usually do. However, with that close of a vote, it’s very difficult to predict what might happen.
“We continue to believe that the totality of evidence presented and discussed today supports the utility of oliceridine as a new analgesic option for the management of moderate to severe acute pain for patients in hospitals or other controlled clinical settings,” said Carrie L. Bourdow, president and chief executive officer of Trevena in a statement at the time.
AcelRx Pharma’s Resubmission of Dsuvia for Moderate-to-Severe Pain
AcelRx Pharmaceuticals has a target action date of November 3 for Dsuvia (sufentanil sublingual tablet). This is a resubmission for the drug after an October 2017 Complete Response Letter (CRL) from the FDA. The FDA requested additional safety data on at least 50 patients dosed at the maximum amount, and second, requested changes to the Directions for Use to accompany the application.
On October 19, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee reviewed the resubmission and voted 10 to 3 in favor of recommended approval. In a statement, the company said, “We appreciate the thoughtful and thorough discussion among the 13 committee members, as well as the forum for public commentary.”
Dsuvia was developed in collaboration with the United States Department of Defense and represents a non-invasive, rapid-acting alternative to intravenous opioids. Its development was partially funded by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC). The drug was approved by the European Medicines Agency (EMA) under the trade name Dzuveo in June 2018.
