The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the 15 products to be subject to IRA-prescripted price negotiations for Medicare this year.
The FDA gave full approval on Thursday for AstraZeneca’s Calquence for previously treated patients with mantle cell lymphoma—an indication for which the drug received accelerated approval for in 2017. In addition, the regulator greenlit Calquence’s use as a part of a first-line combo treatment in MCL patients who are ineligible for autologous hematopoietic stem cell transplantation.
The news came the day before the drug was listed among 14 others as being subject to Medicare price negotatiations this year under the Inflation Reduction Act. According to a factsheet from the Centers for Medicare and Medicaid Services (CMS), Calquence cost the Medicare Part D program $1.6 billion between November 2023 and October 2024 as some 15,000 Medicare beneficiaries took the drug. AstraZeneca has until Feb. 28 to agree to participate in the negotiations.
Calquence is the first BTK inhibitor approved as part of a first-line treatment for MCL, beating out a handful of other companies all pushing through similar molecules through clinical trials. BeiGene and partners Johnson & Johnson and AbbVie were all looking to push their own BTK inhibitors for MCL into the first-line setting. J&J and AbbVie’s Imbruvica was rejected for first-line status in 2022, and in April 2023, the companies said they would withdraw the drug from the market for second-line settings. Meanwhile, BeiGene’s Brukinsa, already approved as a second-line drug for MCL, is currently in Phase III trials for first-line status.
Calquence’s approval was based on a Phase III trial this past summer showing a 27% benefit over placebo on progression-free survival. Data on overall survival for Calquence have not been shown. AstraZeneca noted that when correcting for deaths related to the COVID-19 pandemic, the benefit increased to 36%.
Mantle-cell lymphoma is a rare and aggressive form of non-Hodgkin lymphoma. BTK inhibitors are a relatively uncommon mechanism for cancer drugs. The only other BTK inhibitor on the market is Eli Lilly’s Jaypirca, also used to treat MCL as well as chronic lymphocytic leukemia and small lymphocytic lymphoma. BTK inhibitors work by blocking the action of Bruton’s tyrosine kinase, an enzyme that allows leukemic cells to proliferate in a variety of B cell malignancies.
