(Reuters) -The U.S. Food and Drug Administration on Wednesday said it has approved Bayer’s drug for patients with a type of lung cancer that has advanced or spread despite previous treatments.
The drug, branded as Hyrnuo, is approved for non-squamous non-small cell lung cancer (NSCLC) in patients with mutations affecting the HER2 protein, which plays a crucial role in regulating cell growth and development, as identified by an FDA-approved test.
The company did not immediately respond to a Reuters request for comment.
FDA also approved the Life Technologies Corporation’s test as a companion diagnostic device to help detect the mutations in patients who may be eligible for Bayer’s drug.
Bayer’s oral drug belongs to a class of drugs known as kinase inhibitors, which block the action of protein kinases that regulate cell growth.
Approval of Bayer’s drug also heats up competition with privately held Boehringer Ingelheim’s Hernexeos, another kinase inhibitor, approved in August for a challenging form of lung cancer.
In studies, 71% of the 70 patients who received Hyrnuo, after previous cancer treatments but not those targeting the HER2 mutation, saw their tumors shrink or disappear.
In another group of 52 patients who had prior systemic therapy, including HER2‑targeting treatments, Bayer’s drug helped shrink tumors in 38% of them.
NSCLC is the most common type of lung cancer, with about 80% to 85% of all cases.
Antibody-drug conjugates such as AbbVie’s Emrelis are also approved for a type of NSCLC. The class of therapies acts as “guided missiles” that target only cancer cells while sparing healthy cells, unlike conventional chemotherapy.
Other treatment options for NSCLC include Merck’s blockbuster Keytruda and AstraZeneca’s Tagrisso.
(Reporting by Sriparna Roy in Bengaluru; Editing by Alan Barona and Vijay Kishore)
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