Lumakras is the name of the drug that the Fda (Food and Drgu Administration) approved for administration to a group of cancer patients with a particular one genetic mutation, the Kras.
“Kras mutations have long been considered resistant to drug therapy, representing a real unmet need for patients with certain types of cancer”Said Richard Pazdur, interim head of the FDA’s anticancer drugs division. “Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach.”
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Researchers discovered the drug in late 2017, and now the FDA has approved it based on a mid-phase study showing how the drug helps control the disease in 80.6% of patients. On average, patients taking the drug survived 6.8 months without their tumors getting worse.
“Bring a drug to market in three years it’s something other companies have rarely done in the oncology field, ”said Murdo Gordon, executive vice president for global business operations at Amgen, the pharmaceutical company that will have to complete a larger Phase 3 study to confirm the drug’s benefits in as part of the FDA accelerated approval program.
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Analyst Ronny Gal, however, admitted that there are reasons to be concerned about Lumakras’ long-term business prospects. The drug could indeed does not guarantee benefits in combination with other treatments, and newer and potentially better drugs targeting the Kras mutation are being developed at competing companies. “The long-term value of the drug is far from certain,” concluded Gal.