Amgen Wins FDA Drug Approval For Lung Cancer With Mutation Formerly Resistant To Therapy

Topline

Amgen received regulatory approval from the Food and Drug Administration on Friday for Lumakras, a treatment for lung cancer that some analysts think could become a blockbuster, offsetting recent revenue declines for some of the biotech giant’s other major drugs.

Amgen Set To Join Dow Jones Industrial Average Index — Signage is displayed outside Amgen Inc. headquarters in Thousand Oaks, California, U.S., on ... [+] Thursday, Aug. 27, 2020. Amgen is among the world's biggest biotechnology companies with a market value of about $137 billion, though it's replacing a company -- Pfizer Inc. -- that is about $90 billion larger. Photographer: Patrick T. Fallon/Bloomberg
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Key Facts

Lumakras is the first drug approved to treat KRAS-G12C, a common cancer mutation that researchers have struggled for more than 40 years to target, Amgen said, with many deeming it as “undruggable.”

FDA said the drug shrank tumors with the KRAS mutation in 36% of 124 patients in clinical trials.

About 13% of people in the U.S. with non-small cell lung cancer, or about 25,000 patients annually, currently have the KRAS mutation that Lumakras treats, Amgen said.

FDA warned side effects of the drug include diarrhea, musculoskeletal pain, nausea, fatigue, liver damage and coughing.

Amgen research chief David Reese told Reuters the company is also seeking approval for the drug in Japan and Europe.

Big Number

$17,900. That’s what Amgen said the drug will cost per month in the U.S., while Cowen & Co. projects sales will amount to $138 million in 2022, and climb to more than $1 billion annually in 2026.

Crucial Quote

“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” stated Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence. “Today’s approval represents a significant step.”

Key Background

Analysts will likely closely watch to see if Lumakras sales can offset revenue declines in some of Amgen’s other major drugs. In the first quarter, Amgen’s sales slipped 4% year-over-year to $5.9 billion, below analyst expectations of $6.27 billion. Sales of Amgen’s biggest product, an inflammatory treatment called Enbrel, plunged 20% from the year-ago quarter to $924 million. Sales of another major product, Neulasta, a drug that produces white blood cells for chemotherapy patients, dropped 21% to $482 million in the quarter.

Contra

Bernstein analyst Ronny Gal wrote in a note to clients this week that patients with this cancer mutation sometimes develop “escape mutations” that could reduce the overall effectiveness of drug treatments. In addition, rival companies Eli Lilly and Revolution Medicines are reaching clinical stage trials of drugs to treat KRAS, and they may have better efficacy. “The long-term value of the [Lumakras] drug is far from certain," Gal wrote. "This makes us somewhat more concerned about the long-term outlook of the company."

Tangent

The FDA noted that lung cancer is the most common cancer type and has the highest mortality. The American Lung Association said about 155,000 Americans died from lung cancer in 2018, accounting for one-fourth of all cancer deaths.

What To Watch For

Amgen must now complete a post-approval study ordered by FDA to determine if a lower dosage of the drug could be effective in patients, as cancer drug trials are usually developed at the highest tolerable dose, CNBC noted.

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