A biotech wins the first FDA drug approval in a rare type of eye cancer

The Food and Drug Administration on Tuesday granted approval to the first drug for a rare cancer of the eye that has spread elsewhere or grown too large to be surgically removed. The drug, called Kimmtrak, was developed by the U.K.-based biotech Immunocore. The approval clears Kimmtrak as a treatment for uveal melanoma, a version of the aggressive skin cancer that appears in eye tissue. Less than 2,500 cases are diagnosed each year worldwide, with an estimated 400 eligible patients in the U.S. Though immunotherapies from Merck & Co. and Bristol Myers Squibb are sometimes used to treat the disease, neither have won formal approvals to treat melanoma in eye tissue. Kimmtrak also outperformed Merck's drug and others on measures of survival and tumor spread in a clinical trial. Kimmtrak is the first drug approval for Immunocore, which grew out of research in the 1990s into how immune defenders known as T cells identify and attack diseased cells. The company is relatively small compared to other commercial-stage biotechs, with a market capitalization of just under $1 billion. The drug is also the first of its kind to reach market, a T cell receptor fused to a protein that connects immune cells to cancerous tissue. Immunocore said it expects to launch Kimmtrak commercially "within weeks." The drug will cost an average of around $400,000 per patient, with those eligible expected to take the drug a median of less than six months. The drug is currently forecast to generate around $10 million in sales in 2022 and $50 million in 2023, Jefferies analyst Michael Yee wrote in a Jan. 26 note to clients. The pivotal trial supporting Kimmtrak's approval tested the drug directly against Keytruda, a similar Bristol Myers Squibb medicine called Yervoy or the chemotherapy dacarbazine. Of the 252 patients who received Kimmtrak, 73% were alive one year after the study's start, versus 59% of the 126 patients given the other drugs, a reduction by about half in the risk of death. Kimmtrak also significantly delayed the spread of disease, with 31% of those on Immunocore's drug alive and without tumor progression after six months, compared with 19% of those on other medicines. Immunocore described side effects as manageable, with rash, fever and itching the most common severe side effects from its use. However, there were a small number of cases of an immune-related reaction called "cytokine release syndrome," a common side effect of treatments made from T cells that are genetically modified to seek out and attack tumors. Although fewer than 1% of Kimmtrak patients experienced cytokine release syndrome, the drug's prescribing information will include a boxed warning "as it has the potential to become serious or life-threatening if not managed appropriately," the company said. Immunocore could expand the use of Kimmtrak beyond a rare eye cancer. The drug is in early testing in skin cancer, for instance, as a combination agent with other immunotherapies. Immunocore expects data from that trial by the end of the year.

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