By Joseph Walker
A pathbreaking pill for lung cancer from Amgen Inc. was approved by the U.S. Food and Drug Administration, adding a new potential blockbuster to the biotech giant's aging stable of drugs.
The drug, called Lumakras, was approved 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 medicine that can treat it that the mutation came to be considered "undruggable."
The FDA's approval, which has sped through clinical trials since the first encouraging results in 2019, is a validation for Amgen's drug discovery capabilities, analysts say.
The company's launch of the drug will be closely watched by investors and analysts looking to see Amgen offset declining revenue from older products, including rheumatoid-arthritis drug Enbrel.
An Amgen spokeswoman said the company will charge $17,900 a month for the drug in the U.S. Analysts project the drug could eventually ring up more than $1 billion in annual sales.
The approval is a validation, analysts say, of Amgen's drug-discovery capabilities that have focused on taking advantage of advances in data analytics and genetics to find drug targets.
Company scientists discovered the drug in late 2017 and moved it into clinical trials less than a year later.
The FDA approved Lumakras based on a mid-stage study showing the drug helped control disease in 80.6% of patients; on median, patients taking the drug survived 6.8 months without their cancers worsening.
"This was a three-year sprint to do something that...very few companies have ever done in the field of oncology, and that's get a drug to the market inside three years," said Murdo Gordon, executive vice president for global commercial operations, in an interview. "It's a very big event for the company."
Amgen will have to complete a larger, Phase 3 study to confirm the drug's benefits under the FDA's accelerated-approval program.
In the U.S., 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 annually, according to Amgen.
Most KRAS patients are initially treated with another targeted drug, such as Merck & Co.'s Keytruda, sometimes in combination with chemotherapy. When first-line treatment stops working, patients have few options left, said Bob Li, a medical oncologist at Memorial Sloan Kettering Cancer Center and lead investigator for the Lumakras study.
"For 40 years, we've not been able to crack this and...suddenly patients have a pill they can take once a day and for many patients the tumor will shrink," Dr. Li said in an interview.
Cowen & Co. projects sales of $19 million this year, and $138 million in 2022, and then gradually growing to more than $1 billion annually in 2026.
To achieve those high expectations, however, Amgen will have to show that the drug also works as a first-line treatment option, either in combination or sequentially with other medicines, said Cowen analyst Yaron Werber.
"The chance for a much longer durability of effect, and hence much higher revenues, will depend on its ability to be combined. And there the jury's still out," Dr. Werber said.
Bernstein analyst Ronny Gal said in a note to clients this week that there are reasons to be concerned about the long-term commercial prospects for Lumakras. The drug may not add much benefit in combination with other treatments, and newer, potentially better KRAS-targeted drugs are in development from rivals, Mr. Gal said.
"The long-term value of the drug is far from certain," Mr. Gal said. "This makes us somewhat more concerned about the long-term outlook for the company."
In the first quarter, Amgen's sales were $5.9 billion, down 4% from the same year-earlier period, driven by price concessions.
For many years, Amgen has been known among analysts for its sales and marketing prowess, rather than its scientific discoveries. Yet sales have dropped for some of the company's key franchises -- anti-anemia drug Epogen and cancer supportive-care treatment Neupogen -- after their patents expired.
Meanwhile, some of Amgen's newer drugs, such as its anti-cholesterol drug Repatha, have been commercial disappointments partly because health insurers have limited access, citing high prices.
Write to Joseph Walker at email@example.com
(END) Dow Jones Newswires
May 28, 2021 12:59 ET (16:59 GMT)Copyright (c) 2021 Dow Jones & Company, Inc.