FDA Credits Pilots for Three-Week Review of New Kisqali Indication

Regulatory NewsRegulatory News | 20 July 2018 |  By 

The US Food and Drug Administration (FDA) on Wednesday approved a new indication for Novartis' targeted breast cancer drug Kisqali (ribociclib) after reviewing the drug under two new pilot programs aimed at improving the efficiency of oncology drug submissions and evaluations. 

Using the two programs, FDA says it was able to approve the new indication for the drug less than a month after its formal submission on 28 June 2018. 

"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," said FDA Commissioner Scott Gottlieb. 

The two pilot programs used in the submission and review of the drug are FDA's real-time oncology review and assessment aid program. 

As part of the real-time oncology review, sponsors submit clinical trial data to FDA as it becomes available, allowing the agency to review the data as it comes in before a formal application has been submitted. 

FDA says this program also allows the agency to provide tailored recommendations for the most effective ways of analyzing the clinical trial data to answer key regulatory questions about the product. By the time the sponsor submits a formal application for the product, FDA says it will already be familiar with the data, making the review "more efficient, timely, and thorough." 

Under the assessment aid pilot, sponsors organize their submission into a structured format that allows FDA to insert its assessment into the same file. 

"This voluntary submission form provides for a more streamlined approach to reviewing data and illustrating FDA's analysis. It allows for drug reviewers to focus on the key benefit-risk and labeling issues rather than administrative issues," FDA writes. 

In addition to participating in the pilot programs, Kisqali was also granted priority review and breakthrough therapy designation for the new indication. 

The drug was first approved by FDA in March 2017 for use in combination with an aromatase inhibitor in post-menopausal women with advanced or metastasized HR-positive, HER2-negative breast cancer. 

With the new approval, Kisqali is also indicated to treat pre/perimenopausal or postmenopausal women with HR-postive, HER2-negative advanced or metastatic breast cancer as initial endocrine-based therapy in combination with an aromatase inhibitor and to treat postmenopausal women with HR-postive, HER2-negative advanced or metastatic breast cancer in combination with fulvestrant, as initial endocrine-based therapy or following disease progression on another endocrine therapy. 



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