FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma

November 25, 2014
Randi Hernandez

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

FDA will delay its decision regarding the new drug application for panobinostat.

Novartis announced on Nov. 25, 2014 that FDA extended its Priority Review period by up to three months for its new drug application (NDA) of LBH589 (panobinostat) in combination with Velcade (bortezomib) and dexamethasone for patients with previously treated multiple myeloma.

This announcement follows the decision by an Oncologic Drugs Advisory Committee (ODAC) to vote against recommending approval of the drug earlier this month. Concern stemmed from the observed side effects of panobinostat during the PANORAMA-1 trial and the fact that more patients deaths within 30 days of treatment occurred more frequently in the panobinostat arm compared with placebo. Onclive reported that members of the advisory board did not see an overall survival benefit.

Although Priority Review reduced the standard 12-month review period to eight months, three additional months will be tacked onto the time it will take for FDA to reach a conclusion about the product.

Panobinostat is a pan-deacetylase inhibitor that if approved, could be a first-in-class treatment for patients with relapsed or relapsed and refractory multiple myeloma, according to Novartis. It is an oral, anticancer epigenetic regulator that is thought to inhibit multiple enzymes that cancer cells need to grow and survive. Histone deacetylase inhibitors have historically been used in psychiatry and neurology as mood stabilizers and anti-epileptics.

In a briefing to FDA on panobinostat prior to FDA’s decision to extend, Novartis said its investigational compound “offers a multifaceted approach for the inhibition of cancer cell proliferation and survival” through its effects on histone acetylation and gene expression, as well as on the oncogenic function of non-histone proteins such as Hsp90. "We are committed to working with the FDA as they continue to review the LBH589 NDA," said Alessandro Riva, MD, global head of oncology development and medical affairs, Novartis Oncology, in a press release.

SOURCES:
Novartis
http://www.novartis.com/newsroom/media-releases/en/2014/1873858.shtmlhttp://www.novartis.com/newsroom/media-releases/en/2014/1869569.shtml

FDA
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM421624.pdf