Amgen wins approval for breakthrough lung cancer drug –

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Amgen wins approval for breakthrough lung cancer drug – fr



A revolutionary pill for lung cancer from Amgen Inc.

The drug, called Lumakras, was approved on Friday to treat a portion of lung cancer patients with a particular genetic mutation who have already tried other therapies.

The mutation, known as KRAS, is among the most common found in cancers, but researchers struggled for so many years to find a drug that could treat it that the mutation was considered “indruggable.”
The FDA approval, which has sped up clinical trials since the encouraging first results in 2019, is a validation of Amgen’s drug discovery capabilities, analysts said.

The company’s launch of the drug will be closely watched by investors and analysts who want to see Amgen offset the drop in revenue from older products, including the rheumatoid arthritis drug Enbrel.

An Amgen spokeswoman said the company will charge $ 17,900 per month for the drug as part of the U.S. analysts’ project the drug could potentially generate more than $ 1 billion in annual sales.

The approval is a validation, analysts say, of Amgen’s drug discovery capabilities that have focused on harnessing advances in data analysis and genetics to find drug targets.

Company scientists discovered the drug in late 2017 and took it to clinical trials less than a year later.

The FDA approved Lumakras based on a mid-term study showing that the drug helped control disease in 80.6% of patients; on the median, patients taking the drug survived 6.8 months without their cancer getting worse.

“It was a three-year sprint to do something that… very few companies have ever done in oncology, and that’s getting a drug to market in three years,” said Murdo Gordon. , executive vice president of global business operations, in an interview. “It’s a very big event for the company.

Amgen will need to complete a larger Phase 3 study to confirm the drug’s benefits under the FDA’s fast-track approval program.

In the United States, about 13% of people with non-small cell lung cancer have the type of KRAS mutation that Lumakras treats, or about 25,000 new patients per year, according to Amgen.

Most patients with KRAS are initially treated with another targeted drug, such as Keytruda from Merck & Co., sometimes in combination with chemotherapy. When first-line treatment stops working, patients have few options, said Bob Li, medical oncologist at Memorial Sloan Kettering Cancer Center and principal investigator of the Lumakras study.

“For 40 years we haven’t been able to fix this problem and… suddenly patients have a pill that they can take once a day and for many patients the tumor will shrink,” said Dr. Li in an interview.

Cowen & Co. projects sales of $ 19 million this year and $ 138 million in 2022, and then gradually growing to over $ 1 billion per year in 2026.

However, to meet these high expectations, Amgen will need to show that the drug also works as a first-line treatment option, in combination or sequentially with other drugs, said Cowen analyst Yaron Werber.

“The chances of a much longer lasting effect, and therefore much higher income, will depend on its ability to be combined. And there, the jury is still out, ”said Dr Werber.

Bernstein analyst Ronny Gal said in a note to clients this week that there was reason to be concerned about Lumakras’ long-term business prospects. The drug may not provide much benefit in combination with other treatments, and newer and potentially better-targeted KRAS drugs are being developed by competitors, Mr. Gal said.

“The long-term value of the drug is far from certain,” said Mr. Gal. “It makes us a little more concerned about the long-term outlook for the business.”

In the first quarter, Amgen sales were $ 5.9 billion, down 4% from the same period a year earlier, thanks to price concessions.

For many years, Amgen has been known to analysts for its business and marketing prowess rather than its scientific discoveries. Yet sales fell for some of the company’s key franchises – the anti-anemic drug Epogen and the cancer supportive therapy Neupogen – after their patents expired.

Meanwhile, some of Amgen’s newer drugs, such as its cholesterol-lowering drug Repatha, have been business disappointments in part because health insurers have limited access citing high prices.

Write to Joseph Walker at [email protected]

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