Three Cancer Drugs are Up for FDA Approval in October
September 24, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Analysts are keeping an eye on what drugs are up for approval. Three potential cancer drugs will have decisions made in October, reports The Motley Fool.
Merck’s Keytruda
Kenilworth, N.J.-based Merck & Co. ’s Keytruda is one of a particular hot type of cancer treatment these days, targeting PD-1, a programmed death 1 receptor. The PD-1/PD-L1 pathway has been identified in cancer as important in helping tumors dodge the body’s immune system.
Keytruda has shown a lot of promise for treating a variety of cancers. In March 2015, Merck announced it had halted its pivotal Phase III KEYNOTE-006 clinical trial because it met its two primary endpoints early. That study analyzed KEYTRUDA for the treatment of advanced melanoma, and the drug showed statistically significant and “clinically meaningful improvement in overall survival and progression-free survival compared to ipilimumab.”
The U.S. Food and Drug Administration (FDA) is scheduled to decide on Oct. 2, 2015, whether to expand Keytruda’s label to include patients suffering from non-small cell lung cancer (NSCLC).
In April, the company presented trial results at a meeting of the American Association for Cancer Research, showing the drug’s successes in treating melanoma, lung cancer and mesothelioma. In its study of the drug in NSCLC, the company found 45 percent of patients with high levels of PD-L1 showed positive responses to Keytruda compared to 16.5 percent of patients with PD-L1 levels between 1 to 49 percent.
“The results from this study formed the basis for our Breakthrough Therapy designation and our recent FDA submission for advanced NSCLC, and indicate that tumor PD-L1 expression may be a relevant biomarker to identify patients more likely to have higher rates of response to Keytruda in this tumor type,” said Roger Perlmutter, president of Merck Research Laboratories in a statement.
Merrimack Pharmaceuticals’ MM-398
The FDA is to make a decision on Oct. 24 of Merrimack ’s MM-398 for pancreatic cancer. Merrimack, based in Cambridge, Mass., announced on June 25 that the FDA had accepted the company’s New Drug Application (NDA). The company is hoping for approval for the drug for treatment of metastatic adenocarcinoma of the pancreas in patients who have previously been treated with gemcitabine-based therapy. The FDA also granted the NDA Priority Review status.
The drug hit its primary and secondary endpoints of statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control group in its Phase III NAPOLI-1 study. The drug is also being reviewed by the European Medicines Agency (EMA) for a Marketing Authorization Application (MAA) for the same indications.
The company hopes the drug might be able to replace irinotecan in the FOLFIRI regimen. Irinotecan is marketed as Camptosar by Pfizer and Campto by Yakult Honsha. FOLFIRI is a regimen of cancer treatment that includes folinic acid (leucovorin), fluorouracil (5-FU), and irinotecan.
Amgen’s T-Vec
Thousand Oaks, Calif.-based Amgen has been in the news a lot lately. On Friday the FDA accepted the company’s supplemental New Drug Application (sDNA) for Kyprolis (carfilzomib) for Injection for patients with relapsed myeloma. It also recently received approval for Kyprolis in combination with Revlimid (lenalidomide) and dexamethasone in relapsed multiple myeloma.
On Sept. 16, the company announced it was acquiring Naarden, Netherlands-based Dezima Pharma B.V., that focuses on cholesterol medications. Yesterday the company announced, along with Dublin, Ireland-based Allergan plc (AGN), positive results for a Phase III study on non-squamous cell lung cancer for the drug ABP 215 compared to Avastin (bevacizumab) in adults.
The company’s T-Vec (talimogen laherparepvec) is up for approval from the FDA on Oct. 27. T-Vec is a herpes simplex virus that has been reengineered to replicate inside cancer cells, which will eventually destroy the tumor cells from the inside. It is being evaluated as a treatment for advanced melanoma.
The Motley Fool points out that this drug’s approval isn’t quite as promising or clear as some of its other drugs. In Phase III studies, the drug met its primary endpoint of durable response in advanced melanoma patients, but did not show statistically significant improvement in median overall survival, which was a key secondary endpoint.
In April, 22 of the 23 members of an FDA panel voted in approval. Nonetheless, the panel expressed some concern over the study design. Amgen acquired the rights to the drug in 2011 from Biovex for $425 million and an additional $575 million in potential milestone payments.
Other companies have drugs in this space, including Bristol-Myers Squibb Company (BMY)’s Yervoy (ipilimumab) and Opdivo (nivolumab), and Merck’s Keytruda.
Will the Presidential Election Change the Face of the Way Prescription Drugs are Sold in the United States?
Although Turing Pharmaceuticals announced it will revise its 5,000 percent increase of a newly acquired drug to treat toxoplasmosis, the move sparked a public outcry that resulted in one presidential candidate calling for price caps on prescription medication.
In August, Turing Pharmaceuticals acquired toxoplasmosis drug Daraprim from Impax Laboratories and increased the price of the medication from $13.50 per tablet to $750 per tablet, a 5,000 percent increase. Turing Chief Executive Officer Martin Shkreli defended the increase, saying the revenues would be used to subsidize new research into treatments for toxoplasmosis. Has since said the company will reduce the price, but did not specify what the price would be.
Democratic presidential candidate Hillary Clinton said if elected she would cap monthly out-of-pocket costs for prescription drugs at $250 to avoid “price gouging.” Her comment sent the stock market into a state of flux, with several large companies seeing a drop in their stock of up to 10 percent. The Nasdaq Biotechnology Index dropped 4.4 percent and the SPDR S&P Biotech ETF dropped by 6 percent.
BioSpace wants to know what you think: Will the presidential election change the face of the way prescription drugs are sold in the United States?