Amgen Drug Wins US Approval for Type of Advanced Lung Cancer

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Amgen Inc. won US approval for a new drug to treat a particularly aggressive form of advanced lung cancer, providing a badly needed new option for patients when chemotherapy stops working.

Amgen's drug is among the few treatments cleared for patients with small cell lung cancer whose tumors have stopped responding to chemo. The US Food and Drug Administration granted it accelerated approval, a shortcut to the market for urgently needed therapies, after a study showed it shrank tumors in about 40% of patients who received it after other treatments failed to work. 

About 35,000 Americans annually are diagnosed with small cell lung cancer, a rapidly growing form of the disease that's heavily tied to past smoking. Most cases have spread widely by the time they're found, and while chemotherapy often works at first, the cancer almost always comes roaring back, leaving patients with few options. 

Amgen's shares were down 1.3% as of 3:30 p.m. on Thursday.

Small cell lung cancer is "one of the most aggressive, metastatic, rapidly proliferating cancers that there is," said Jay Bradner, Amgen's head of research and development, in an interview before the approval. The treatment landscape "hasn't really evolved in the last 30 years."

That's why cancer doctors are excited about Amgen's drug, Imdelltra, even though it has only undergone two of the three stages of human testing normally needed for approval and hasn't yet been shown to extend patient survival. The treatment could drive roughly $460 million in sales for Amgen by 2027, according to analysts surveyed by Bloomberg Intelligence.

Amgen's drug is a bispecific T-cell engager, a type of therapy that harnesses the body's own immune system to target and fight cancer cells. Imdelltra was designed to latch onto immune T cells — white blood cells that destroy threatening invaders — with one arm while targeting a protein on the surface of the tumor cell with the other.

The technology "is like hiring a hit man" for cancer, Bradner said.

In the trial that led to approval, a 10 milligram dose of the drug held tumors at bay for a median of 4.9 months before cancer progressed, and patients survived for a median of 14 months, according to results published last year in the New England Journal of Medicine. While the trial had no comparison group, patients who have failed other treatments for small cell lung cancer usually survive an average of around six months or less. Side effects of Amgen's drug included a nasty reaction called cytokine release syndrome, as well as fever, anemia, constipation and decreased appetite.

The FDA put what's known as a "black box" on the drug, which warns doctors about the potential for cytokine release syndrome as well as serious neurotoxicities in patients on the drug. Cytokine release syndrome can be life threatening.

As part of the sped-up approval, Amgen's required to conduct additional studies to confirm the drug leads to concrete patient benefits such as longer life. The drugmaker is gearing up for a 550-patient study to assess whether the drug extends survival when given as a second-line treatment in combination with another immune therapy for small cell lung cancer, AstraZeneca's Imfinzi, according to a posting on clinicaltrials.gov, a US government website.

Amgen also plans to study the drug as an initial treatment for small cell lung cancer.

Other companies are hot on Amgen's heels in developing new immune therapy drugs for small cell lung cancer. In March, Merck & Co. completed the acquisition of cancer startup Harpoon Therapeutics Inc. for more than $650 million. Harpoon's lead drug in the field, another T-cell engager, hits the same target on cancer cells as Amgen's and is being tested in combination with an immunotherapy. German drugmaker Boehringer Ingelheim GmbH is studying a similar drug for the condition.

With assistance from Robert Langreth.

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