FDA grants orphan drug designation to LAVA-051 for CLL
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The FDA granted orphan drug designation to LAVA-051 for the treatment of chronic lymphocytic leukemia.
LAVA-051 (Lava Therapeutics) is a bispecific antibody that activates the immune system to attack CD1d-expressing cancer cells.
Enrollment is underway for an open-label, multicenter phase 1/phase 2A trial designed to evaluate the agent for patients with relapsed or refractory CLL, multiple myeloma and acute myeloid leukemia.
Data from the phase 1 dose-escalation phase are expected in the first half of 2022. Topline clinical data from the phase 2A expansion cohorts are expected in the second half of next year.
“We are excited to receive our first orphan drug designation from the FDA for LAVA-051, our most advanced product candidate from our off-the-shelf Gammabody platform that is designed to unlock the full anti-cancer potential of this specialized effector cell population,” Stephen Hurly, president and CEO of Lava Therapeutics, said in a company-issued press release. “This designation will be helpful in enhancing our communication with the FDA on our development of LAVA-051. We are grateful to the FDA for highlighting the need for new and improved therapies to address the unmet needs in CLL.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
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