Nov 19 (Reuters) - The U.S. Food and Drug Administration

said on Wednesday that it has approved Bayer's drug

for patients with a form of lung cancer that has advanced or

spread despite earlier 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.

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.

The monthly list price for Hyrnuo is $24,000.

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.

Hyrnuo's approval "provides a welcome addition to the

treatment space," said Bayer executive Chandrasekhar Goda.

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 ( ABBV ) 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 ( MRK )

blockbuster Keytruda and AstraZeneca's ( AZN ) Tagrisso.

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.