Trailing in the wake of Pfizer’s Ibrance, Novartis’ Kisqali is one step closer to nabbing a regulatory boost.
The FDA has granted the breast cancer fighter its breakthrough designation as a first-line treatment for premenopausal women with HR-positive, HER2-negative breast cancer. The tag sets Kisqali up for a speedy approval in premenopausal breast cancer, which Novartis says is the leading cause of cancer death in women ages 20 to 59.
"Younger women often have distinct treatment goals and needs, and it is important for oncologists to offer effective and well-studied treatment options for their specific disease,” Novartis Oncology’s head of global drug development, Samit Hirawat, said in a statement, adding that the company looks forward to making the therapy available in the U.S. “as soon as possible.”
The FDA expedited Kisqali’s review based on data showing that the treatment, in combination with tamoxifen and goserelin, could keep cancer at bay for a median 22.1 months, compared with 11 months for tamoxifen and goserelin alone; when paired with an aromatase inhibitor and gosrelin, Kisqali staved off cancer progression for 27.5 months, compared with the 13.8 months goserelin and an aromatase inhibitor posted on their own.
Novartis is looking to give Kisqali a lift in a competitive field that hasn’t gotten any less tough since the med arrived last March. Pfizer’s Ibrance has dominated the space since launching in early 2015, and Eli Lilly’s Verzenio arrived in September to take the market-share battle up a notch.
That’s not to say Pfizer isn’t also playing in the premenopausal field, though. The drug bears an indication for use with fulvestrant in women whose cancer has progressed following endocrine therapy.