Has Cancer Research Become Cancerous? Same Cancer Strategy Targeted By 'Too Many Drugmakers,' Say Regulators
The new type of drug that uses the body's immune system to fight cancers has hit the bulls eye. But, Reuters has reported that a top U.S. regulator is concerned too many companies are focused on the same approach. This approach disables the PD-1 protein tumors use to dodge the immune system.
'Crowded' Space In Oncology
The FDA has approved treatments utilizing this strategy from Merck & Co., Inc. (NYSE: MRK), Bristol-Myers Squibb Co (NYSE: BMY) and Roche Holding Ltd. (ADR) (OTC: RHHBY). Reuters highlighted, "At least five other drugmakers are developing similar medicines."
"People should ask themselves ... would we be better off spending those resources into looking at more novel drugs?" Dr. Richard Pazdur, head of the Food and Drug Administration's office of oncology products, told Reuters during the annual American Society of Clinical Oncology (ASCO) meeting in Chicago.
Reuters said Merck's Keytruda has been shown to increase the lifespan of advanced melanoma patients, aiding a significant number of these patients live three-plus years. Bristol-Myers' Opdivo has prolonged life for a few lung cancer patients by two years. These facts and figures were presented at the ASCO meeting.
Pazdur said the number of similar drugs simultaneously in development is a first, "and latecomers to the PD-1 market will likely be relegated to 'niche' indications."
AstraZeneca plc (ADR) (NYSE: AZN) PD-1 received "breakthrough" status from the FDA, which will expedite the drug's review for treating a type of bladder cancer.
Reuters noted other companies in earlier stages of development include Pfizer Inc. (NYSE: PFE), Merck KGaA(ADR) (OTC: MKGAY), Novartis AG (ADR) (NYSE: NVS), Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Beigene Ltd (ADR) (NASDAQ: BGNE).
Reuters reported differing opinions toward oncology's "crowded" status, interviewing Pazdur and other drug campy executives. While Pazdur remains critical, Reuters summarized other perspectives by saying, "[T]he science around cancer is advancing rapidly, with a focus on how to best combine therapies to attack multiple mechanisms of the disease, determine which patients are most likely to respond to them and how long patients will need to be treated."
"Our reason to go into PD-1s is not just to have a 'me too' drug," said Israel Lowy, head of translational science and oncology at Regeneron. "Most people think that the future is in combinations ... Having our own PD-1 that is active and useful gives us enormous flexibility in how we do clinical trials."
Leerink Partners pharmaceutical analyst Seamus Fernandez told Reuters that Bristol-Myers could "win the war" — "if it succeeds with a combination of Opdivo and its other immunotherapy Yervoy as an initial treatment for advanced non-small cell lung cancer."
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