The FDA announced Friday approval of Roche's Kadcyla (ado-trastuzumab emtansine), previously known as T-DM1, for patients with HER2-positive metastatic breast cancer (mBC). The antibody-drug conjugate, which was assessed under the agency's priority review programme, is intended for patients who have previously been treated with Herceptin (trastuzumab).
"Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth," remarked Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, adding it "delivers the drug to the cancer site to shrink the tumour, slow disease progression and prolong survival." The agency noted that Kadcyla will carry a boxed warning informing patients of the drug's ability to cause liver and heart toxicity and death as well as birth defects.
The FDA's approval was based on the EMILIA study involving 991 patients with HER2-positive locally advanced breast cancer or mBC who had previously received Herceptin and a taxane. Results of the study showed that among patients who received Kadcyla, overall survival was 30.9 months, compared to 25.1 months for those who received GlaxoSmithKline's Tykerb (lapatinib) in combination with Roche's Xeloda (capecitabine). Additionally, progression-free survival was 9.6 months in the Kadcyla arm, versus 6.4 months in the Tykerb plus Xeloda arm.
Kadcyla, which was developed using ImmunoGen's TAP technology, will be priced at $9800 a month and is expected to cost up to $94 000 for a treatment course based on patients taking it for 9.6 months, according to Roche's Genentech unit. Sandra Horning, head of global oncology at Roche, said "we see great potential for this molecule starting in the metastatic setting but with the potential to move into early breast cancer as well." Genentech indicated that Kadcyla will be available to people in the US within two weeks.
Roche has also submitted marketing applications for Kadcyla to other regulators around the world, including the European Medicines Agency, for the treatment of people with HER2-positive mBC. Jefferies analysts predict that the drug could generate annual peak sales of $1.9 billion as usage in other settings increases.
For related analysis, see ViewPoints: Why Roche's Kadcyla approval will put cancer drug prices back in the spotlight.
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