Roche’s combo lymphoma treatment wins U.S. FDA approval

(This June 10 story deletes paragraph 9 to clarify that retreatment with Polivy has not been studied.)

(Reuters) – The U.S. Food and Drug Administration on Monday granted earlier-than-expected approval to Roche Holding AG’s antibody- Polivy for treatment of patients with advanced lymphoma.

Polivy was approved in combination with Roche’s older drug Rituxan and a chemotherapy agent for adult patients with advanced diffuse large B-cell lymphoma (DLBCL) whose cancer has worsened despite at least two previous lines of therapy.

Antibody-drug conjugates are designed to deliver a toxic chemotherapy directly to tumors. Roche said the average U.S. list price for a four-month course of Polivy would be $90,000. Rituxan is priced at $39,500 for four months.

Wall Street analysts estimate Polivy sales at nearly $1 billion by 2024, according to IBES data from Refinitiv.

Side effects seen in studies of Polivy included low blood cell counts, nerve damage, fatigue and pneumonia, the FDA said in a statement.

Cell therapies Yescarta, from Gilead Sciences Inc and Kymriah, sold by Novartis AG, are also approved for patients with advanced DLBCL.

Dr. Matthew Matasar, a hematologist at New York’s Memorial Sloan Kettering Cancer Center who was involved in the development of Polivy, said the drug could be an option for some patients to try before determining whether they need to move on to CAR-T treatments.

Roche estimates that nearly 25,000 new cases of DLBCL, a type of non-Hodgkin’s lymphoma (NHL), will be diagnosed in the United States this year. NHL, which is one of the most common cancers, accounts for about 4% of all types of cancers in the United States, according to the American Cancer Society. Continued approval for the treatment may depend on data from a confirmatory trial, Roche said. The FDA’s accelerated approval program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.