Dive Brief:

• The Food and Drug Administration on Thursday granted accelerated approval to a new dual-acting drug from Amgen to treat small cell lung cancer in people whose disease has progressed following chemotherapy.

• The drug, which will be sold as Imdelltra, is an immunotherapy that helps T cells home in on tumor cells by binding to protein flags on the surface of both. It is the tenth so-called “bispecific” antibody to gain FDA approval in cancer, and the first in small cell lung cancer.

• The FDA approved Imdelltra more than three weeks ahead of its deadline, and based its decision on a trial showing the drug shrank tumors in 40% of patients who received it. Amgen will need to complete another study testing Imdelltra against another active treatment to confirm its benefit and place on the market.

Dive Insight:

Small cell lung cancer represents about 14% of all lung cancer cases, and hasn’t drawn as much research as the more common non-small cell disease. Until recently, chemotherapy has been the main form of treatment, and patients had a poor survival outlook.

As in many other areas of cancer care, however, immunotherapies have changed how the disease is treated. Tecentriq from Roche and Imfinzi from AstraZeneca gained approval in 2019 and 2020, respectively, to be used alongside chemotherapy in people newly diagnosed with the “extensive stage” form of the disease, in which cancer has spread beyond the primary site.

Amgen’s bispecific antibody targets a protein called delta-like ligand 3, which also was the aim of an AbbVie antibody-drug conjugate called rovalpituzumab tesirine that failed in testing.

Amgen’s bispecific approach follows the success of other dual-targeting antibodies in blood cancers, like Johnson & Johnson’s Tecvayli for multiple myeloma. Imdelltra engages the same CD3 protein on T cells.

Known scientifically as tarlatamab, Indelltra is only for patients once they progress following chemotherapy. On chemotherapy alone, patients can expect to live on average another 10 months, while the addition of Imfinzi added three more months and Tecentriq two more months in clinical trials.

Like other bispecific antibodies, Imdelltra is associated with a serious immune-related side effect called cytokine release syndrome, which in testing mostly occurred after the first and second doses. The FDA label instructs patients to stay within one hour of a medical center following the first doses to allow for monitoring, and also instructs doctors to interrupt or discontinue care in severe cases.

Imdelltra’s approval represents “a meaningful improvement over current options, and there is no approved standard of care,” William Blair analyst Matthew Phipps wrote in a note to clients. Phipps estimated Imdelltra sales will reach $842 million in 2028, based on disease prevalence and the drug’s price, which Amgen set at $31,500 for the first cycle and $30,000 for subsequent cycles.

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