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Thursday, 08/15/2019 11:12:06 AM

Thursday, August 15, 2019 11:12:06 AM

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Discussion on Precision Medicine's from Xconomy

The FDA has approved two cancer drugs that target a tumor’s genomic signature, no matter where in the body that tumor is found. One of those “tissue agnostic” approvals was for the immunotherapy pembrolizumab (Keytruda), which is already used to treat a slew of cancer types. Larotrectinib (Vitrakvi), from Loxo Oncology, got the second nod, prompting Eli Lilly to buy Loxo for $8 billion, even though rival Bayer held claim to the drug’s commercial rights.

The third could come this weekend. Last month entrectinib (Rozlytrek) nabbed the first “tissue agnostic” approval in the history of Japan. Now the FDA will decide whether to approve Rozlytrek, which Roche grabbed when it bought Ignyta for $1.7 billion. Like Viktravi, Rozlytrek is for people whose tumors have an NTRK gene that has abnormally fused to another gene. The FDA is deciding whether to approve it for those patients, and it will also weigh the drug’s prospects for non-small cell lung cancer patients with a different fusion called ROS1.

The field of precision medicine, matching the right drug to the right patient, holds out the promise of less trial-and-error (and ideally, fewer side effects and more lives saved). But the commercial success of both Vitrakvi and Rozlytrek are every bit as important as touchstones for the economic viability of these drugs. Several others are in development, aiming for the same path as Vitrakvi and Rozlytrek.
https://xconomy.com/national/2019/08/15/four-new-drugs-are-around-the-corner-heres-what-you-need-to-know/?single_page=true

One basket trial later, pozi will be in that discussion for exon 20.