Breast cancer drug first to get nod in FDA accelerated approval program

July 24, 2018

A breast cancer drug is the first approval from FDA in 2 new pilot programs that make the development and review of cancer drugs more efficient.

A breast cancer drug is the first approval from FDA in 2 new pilot programs that make the development and review of cancer drugs more efficient.

Ribociclib (Kisqali, Novartis), which was originally approved by FDA last March as initial endocrine-based therapy for postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, snagged an expanded indication from FDA.

Kisqali can now be used in combination with an aromatase inhibitor to treat pre/perimenopausal or postmenopausal women with HR+, HER2 negative advanced or metastatic breast cancer, as initial endocrine-based therapy. Kisqali can also now be used in combination with fulvestrant (Faslodex, AstraZeneca) to treat postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

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“This approval gives Kisqali the broadest first-line indications of any CDK4/6 inhibitor for the treatment of HR+/HER2- advanced breast cancer,” Samit Hirawat, MD, head of Novartis’s Oncology Global Drug Development, told FormularyWatch.

Around 155,000 women in the United States are living with metastatic breast cancer, and it is estimated that 70% of advanced breast cancers are HR+, Hirawat said. "Now all women diagnosed with HR+/HER2- advanced or metastatic breast cancer, including premenopausal and postmenopausal women, can feel confident in Kisqali combination therapy as a first-line treatment option in combination with any aromatase inhibitor.”

Kisqali has a flexible pricing structure, based on the dose. The wholesale acquisition cost (WAC) for a 28-day supply of Kisqali ranges from $4,782 to $11,955, depending on the dose. Plus, the WAC price is not the price that patients will pay for their medicine. "The actual out-of-pocket cost for patients is based on their individual healthcare insurance plans,” Hirawat said.

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Novartis provides eligible patients with affordable access to Kisqali through the Kisqali Care Navigator program. “The majority of patients in the United States with commercial insurance will pay $0 per month for their Kisqali prescription,” Hirawat added.

FDA reviewed Novartis's supplemental New Drug Application using its Real-Time Oncology Review and Assessment Aid pilot programs and approved the application less than one month after submission.

With the real-time review, the agency was able to start evaluating the clinical data as soon as the trial results became available, “enabling FDA to be ready to approve the new indication upon filing of a formal application with the Agency,” FDA said in a statement.

“These new programs were designed to reduce some of the administrative issues that can add to the time and cost of the review process, including the staffing burdens on the FDA,” the agency said. “With this approval, we’ve demonstrated some of the benefits of the new programs that we’re piloting for our review of cancer drugs, to improve regulatory efficiency while enhancing the process for evaluating the data submitted to us.”

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