Novartis pulls EMA app for new Tasigna use, but wins new NICE nod for Gleevec

As blood cancer wonder-drug Gleevec ages, Novartis ($NVS) is trying to build out indications for follow-up Tasigna. After an up-and-down week for the pair, the Swiss pharma is now short a potential Tasigna label expansion, thanks to a snag in Europe. But a change of heart for the U.K.'s cost watchdog on Gleevec may give the franchise a boost.

Novartis has pulled an EMA app for Tasigna in patients with Philadelphia-chromosome-positive chronic myelogenous leukemia (CML) who did not achieve "complete molecular response" when treated with Gleevec, PMLiVE reports. The Basel-based drugmaker made the decision after the agency's scientific advisory committee deemed Novartis' data insufficient for the new use, Novartis said in its withdrawal letter.

While Tasigna already has the EU's green light for treating Philadelphia-chromosome-positive CML, its use is restricted to patients with chronic or accelerated forms of the disease who can't tolerate other therapies--including Gleevec, PMLiVE points out.

Novartis hasn't necessarily given up on scoring the new use, noting that it reserves the right to submit again, once it rounds up more data. But in the meantime, it got a lift from the U.K., whose cost-effectiveness gatekeeper flip-flopped a three-and-a-half-year-old guidance. The National Institute for Health and Care Excellence (NICE) now recommends Gleevec--called Glivec in Britain and elsewhere--as a treatment for digestive system tumors.

Now that data from ongoing trials has provided evidence in Glivec's favor, NICE's nod will cover the use of the drug as an adjuvant treatment for up to three years for adults who are at high risk of relapse after surgery for KIT-positive gastrointestinal stromal tumors, PharmaTimes reports.

NICE's Carole Longson

"When the original guidance was published, the committee felt there wasn't enough evidence about key aspects of the clinical effectiveness," of Glivec, NICE's health technology evaluation center director Carole Longson told PT. But now, NICE is "pleased to be able to propose recommending the drug," she said.

Lately, the spotlight has been on the cancer med's IP woes rather than its regulatory victories, with India's Supreme Court recently refusing Indian patent protection on the drug after a lengthy battle. Tasigna, however, has made its name as a blockbuster, generating $1.3 billion in 2013 U.S. sales on the way to the $2.58 billion analysts see in its future for 2018.

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