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Novartis grabs blockbuster cancer nod for Piqray on double good news day

Novartis’ breast cancer drug Piqray has become the first new molecular entity approved under the FDA’s Real-Time Oncology Review pilot program. (Novartis)

Novartis’ promise of 25 potential blockbuster launches is steadily coming to fruition. On the same day the FDA approved gene therapy Zolgensma, the U.S. regulator also waved through breast cancer drug Piqray.

Also known as alpelisib, or BYL719, Piqray boasts two firsts. One, it is the first drug meant specifically for HR+/HER2- breast cancer patients with a PIK3CA mutation. And, it’s the first novel drug approved under the FDA’s Real-Time Oncology Review pilot program, which allows for faster evaluation of breakthrough cancer drugs, the agency said.

Eager to unleash the drug’s blockbuster potential as soon as possible, Novartis has already launched Piqray with a list price of $15,500 for a 28-day supply, a company spokeswoman told FiercePharma.

PIK3CA mutations account for 40% of all HR+/HER2- breast cancer cases and are associated with poor disease prognosis. Currently approved in combination with AstraZeneca’s endocrine therapy Faslodex in PIK3CA-mutated men or postmenopausal women who have progressed on an endocrine regimen, Piqray could steal some share from Pfizer’s Ibrance and Eli Lilly’s Verzenio in second-line metastatic HR+/HER2- breast cancer. Now, with an FDA-approved diagnostic kit by Qiagen, doctors will be able to identify those with the PIK3CA mutation and will likely assign them to the Novartis drug.

Several other PI3K inhibitors have entered the market before Piqray, including Gilead Sciences’ first-in-class Zydelig, Bayer’s Aliqopa and Verastem Oncology’s recently approved Copiktra. But only Piqray is indicated in breast cancer, or solid tumors in general. Roche once had taselisib also in development for advanced breast cancer but ditched the program last year on weak data.

In the phase 3 Solar-1 trial of 572 patients, the Piqray-Faslodex combo delayed time to tumor progression or death to 11 months, almost doubling the 5.7 months posted by Faslodex alone. And the results were similar among subgroup patients who had previously received a CDK 4/6 inhibitor, such as Ibrance or Novartis’ very own Kisqali, according to the company.

The nod adds to Novartis’ breast cancer portfolio. Last year, Kisqali nabbed expanded FDA approvals in tandem with an aromatase inhibitor to treat newly diagnosed HR+/HER2- patients and with fulvestrant as both initial or second-line treatment. Those additions just happened to be the first FDA approvals under the Real-Time Oncology Review program. With the expansions in tow, the drug hauled in $91 million in the first quarter, 20% ahead of analysts’ expectations, according to Jefferies.

Piqray is one of four potential blockbuster launches Novartis has highlighted for 2019. Before the Friday approvals for spinal muscular atrophy gene therapy Zolgensma and Piqray, the FDA green-lighted the Swiss drugmaker’s Mayzent as the first oral drug for secondary progressive multiple sclerosis.

The company has also used a priority review voucher to secure an FDA decision in 2019 for its wet age-related macular degeneration candidate brolucizumab—a potential threat to Bayer and Regeneron’s Eylea and even Novartis’ own Roche-partnered Lucentis.