|
 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 therapy Yescarta, from Gilead Sciences Inc and Kymriah and sold
by Novartis AG, is 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.
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He said Polivy can only be used once due to the risk of serious
neurotoxicity.
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.
(Reporting by Aakash Jagadeesh Babu in Bengaluru and Deena Beasley
in Los Angeles; Editing by James Emmanuel and Lisa Shumaker)
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