7. LEE011

Novartis doesn’t view “relatively routine” monitoring “as an undue burden” for an LEE011 (ribociclib) launch, global R&D chief Vas Narasimhan said in a January interview.

Generic name: ribociclib
Company: Novartis
Disease: breast cancer
2022 sales estimate: $1.6 billion

Novartis’ LEE011, also known as ribociclib, is revving up to challenge Pfizer's hot-selling Ibrance in the CDK 4/6 field. Despite some safety concerns that have worried investors, EP analysts see the prospect easily topping the blockbuster mark by 2022.

Back in November, LEE011 snagged the FDA’s priority review tag, hastening its trip down the regulatory pathway. It did so on the back of strong phase 3 data, with efficacy that prompted Bernstein analyst Tim Anderson to compare it and Ibrance to “twins separated at birth.”

The analogy doesn’t hold on the safety front, though, where incidences of drug-induced liver damage and mild cardiac arrhythmias—as well as one drug-related sudden death—has left industry-watchers questioning whether the Novartis product might wear a black-box warning upon FDA approval. Regardless, Novartis itself is considering adding “some additional monitoring” of patients on the drug, execs said on the company’s Q3 conference call.

Not everyone liked that news; Credit Suisse analyst Vamil Divan, for one, predicted that the safety hurdles could drag LEE011 down below Eli Lilly prospect abemaciclib. But Vas Narasimhan, Novartis’ global head of drug development, told FiercePharma in a January interview that “oncologists are used to monitoring the use of agents in these patients” and that Novartis doesn’t view the “relatively routine” monitoring “as an undue burden.”

Going forward, the company is also looking to generate “real, pivotal” data in premenopausal women, and “part of our LEE strategy is to be the first company” to do it, Narasimhan said.

7. LEE011