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Tuesday, Sep 27, 2022
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FDA OK for Lumakras Opens Lung Market

Lumakras, an oral tablet from Amgen Inc. made for the treatment of metastatic non-small cell lung cancer, was given accelerated approval from the U.S. Food and Drug Administration.   Lumakras has a U.S. list price of $17,900 per month.

“The FDA approval of Lumakras is a breakthrough moment for patients with KRAS G12C-mutated non-small cell lung cancer because there is now a targeted therapy for this common, but previously elusive, mutation,” Dr. David Reese, Amgen’s executive vice president of research and development, said in a statement.

KRAS G12C is the most common KRAS mutation and accounts for about 13 percent of mutations in patients with non-small cell lung cancer. For more than 40 years, mutant KRAS has been deemed by cancer researchers as undruggable due to its unorthodox shape as a protein.   In an equity research report by investment bank Oppenheimer & Co. Inc., analysts wrote that they expect Lumakras to have a smooth launch despite lingering COVID-19 headwinds. They cited Amgen’s “seasoned sales team and pre-commercialization efforts” as the reason for their outlook.   Oppenheimer analysts also noted that Amgen continues to leverage educational awareness campaigns among physicians and patients. They added that key marketing efforts by Amgen focus on community centers where more than 80 percent of non-small cell lung cancer patients are diagnosed and treated.

Brokerage Jefferies Group also shared a positive outlook on Lumakras.

“We predict launch will be solid and ahead of fiscal year 2021 cons of $100 million and could be closer to $150 million to $200 million, possibly based on other similar comparable targeted mutation lung cancer launches,” Jefferies analysts wrote. They maintained a “Buy” rating on Amgen stock.

Both Jefferies and Oppenheimer lauded Lumakras’ regulatory approval, which took less than three years. Jefferies called Lumakras’ speedy approval an incremental positive for Amgen, although it was well expected.

Oppenheimer said Amgen is in a position to maintain long-term revenue growth as the company’s R&D continues to push out new products while mature products fade. A gradual decline in revenues and EPS is estimated by Oppenheimer if Amgen’s pipeline assets, such as Lumakras, are disrupted or fail to launch.

A week after Lumakras received FDA approval, Amgen presented promising data from the phase II results of its CodeBreak 100 clinical study for Lumakras. In the study, Lumakras showed median overall survival of 12.5 months in patients with previously treated non-small cell lung cancer. Median survival is indicative of how long patients survive with a disease in general or after a particular treatment.

“The results published in the New England Journal of Medicine further confirm the deep and durable responses we have seen with Lumakras throughout the CodeBreak clinical trial program, the most advanced KRAS G12C clinical trial program with the longest follow-up,” Reese said in a statement.

The FDA will require that Amgen conduct a post-marketing trial to determine if a lower dose of Lumakras will yield a similar clinical effect to the initial trial dosage of 960 mg.

Antonio Pequeño IV
Antonio Pequeño IV
Antonio “Tony” Pequeño IV is a reporter covering health care, finance and law for the San Fernando Valley Business Journal. He specializes in reporting on some of the biggest names in the Valley’s biotechnology sector. In addition to his work with the Business Journal, Tony has reported with BuzzFeed News on the unsupervised use of Clearview AI, a controversial facial recognition technology. Tony, who also conducts freelance reporting, graduated from the USC’s Master of Science in Journalism program in 2021. He is in his fifth year as a journalist as of 2021.
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