Novartis' (NVS) LBH589 Gets Unfavorable FDA Panel Opinion
Novartis (NVS) received disappointing news when the FDA’s Oncologic Drugs Advisory Committee (:ODAC) did not recommend its pipeline candidate LBH589 (panobinostat) for the treatment of multiple myeloma in combination with Velcade and Decadron.
Although the FDA is not bound to follow the ODAC’s recommendations, it generally takes it into account.
The LBH589 submission included data from the global registration phase III trial, PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) and a phase II trial in the U.S., PANORAMA-2.
In Dec 2013, results from PANORAMA-1 had showed that LBH589 plus Velcade and Decadron met the primary endpoint of extending progression-free survival (PFS) as compared to Velcade plus Decadron and placebo. In Jun 2014, results from the study showed that LBH589 in combination with Velcade and Decadron showed a 37% improvement in progression-free survival (PFS) among patients suffering from relapsed or relapsed and refractory multiple myeloma as compared to treatment with the same regimen with placebo in patients. Consequently, the study met its primary endpoint.
We note that the candidate was granted priority review status by the FDA in May 2014.
The successful development of LBH589 would have boosted Novartis’ portfolio to a large extent which is facing generic competition for several of its key drugs such as Gleevec, Zometa and Diovan Mono.
Novartis, a large cap pharma, currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked large cap pharmas may consider companies like Allergan (AGN), AbbVie (ABBV) and Bristol-Myers Squibb Company (BMY). All three carry a Zacks Rank #2 (Buy).
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