Drug Development

Novartis’ star cancer drug lands on an inside FDA track, racing Lilly to a showdown with Pfizer

Novartis just got a helping hand from the FDA as it races against Eli Lilly to jump into a three-way tug of war with Pfizer over a blockbuster cancer drug market. The agency has given its CDK 4/6 cancer drug LEE011 (ribociclib) its breakthrough status, likely cutting months off the regulatory review process.

Novartis gained a BTD — its 11th — for the drug in combination with letrozole for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.

Novartis will want every edge it can get in this race. Pfizer led the way on this new cancer drug category with its accelerated approval of Ibrance (palbociclib) early last year. But both Lilly and Novartis still see plenty of blockbuster opportunities as they look to notch their first approvals in the field.

Novartis was able to tout positive progression-free survival results from its MONALEESA-2 trial, which formed the basis for its breakthrough application. Data from that study has yet to be posted.

Lilly’s abemaciclib may be behind in the race, not unusual for the methodical drug developers at the company. But as Dana Farber’s Geoffrey Shapiro told me in May, research has shown that the drug appears suitable for continual dosing rather than the three weeks on/one week off regimen used for Novartis’ and Pfizer’s drugs. That, along with some better early results for use as a monotherapy rather than in a combination, may help Lilly seize a bigger share of the market.

And it’s a big market. Ibrance sales shot up to $514 million in the second quarter of this year, about half of the total for its oncology division. It’s at $942 million for the half. And analysts typically dole out peak sales forecasts in the billions for these three drugs.

Novartis Oncology chief Alessandro Riva

Novartis Oncology chief Alessandro Riva

The FDA’s breakthrough drug program has had a particularly marked effect in the cancer field, where regulators like Richard Pazdur have openly embraced the 4-year-old process to speed along new remedies. One recent analysis concluded that BTD approvals snipped an average of about three months off of the review stage.

“This designation shows the potential of LEE011, and we look forward to close collaboration with the FDA and the advanced breast cancer community to provide a new treatment option for women living with HR+/HER2- advanced breast cancer as quickly as possible,” said Novartis Oncology chief Alessandro Riva in a statement.

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