Bristol-Myers Squibb Company
) announced that it intends to seek FDA approval for its high
potential immuno-oncology drug Opdivo (nivolumab, a PD-1 immune
checkpoint inhibitor) for the advanced melanoma indication in
previously treated patients by Sep 30, 2014. The news of the
impending filing boosted Bristol-Myers' shares.
Bristol-Myers said in its press release that it will seek FDA
approval for the advanced melanoma indication on the basis of
positive results from a phase III study (Checkmate -037). The
patients in the trial were previously treated with Bristol-Myers'
marketed skin cancer drug Yervoy and with a BRAF inhibitor regimen
in case they were BRAF-mutation positive. We note that Opdivo was
approved in Japan earlier this month for treating patients with
Following the Japanese approval, Opdivo became the first PD-1
immune checkpoint inhibitor to gain approval. Ono Pharmaceutical
has the rights to commercialize the treatment in Japan as per a
2011 agreement with Bristol-Myers.
We note that another anti-PD-1 antibody,
) pembrolizumab (MK-3475), is under FDA review for treating
unresectable or metastatic melanoma in patients pretreated with
Yervoy. A decision is expected by Oct 28, 2014. Hence it is likely
that Merck will be the first company to receive FDA approval for an
anti-PD-1 therapy. The candidate is also under review in the EU.
Bristol-Myers is already seeking FDA approval for Opdivo in another
oncology indication, namely, third-line squamous cell non-small
cell lung cancer. The biopharmaceutical major initiated a rolling
submission for the indication based on results from the 063 study.
Bristol-Myers expects to complete the rolling submission by Dec 31,
Approval of Opdivo for the above indications would strengthen
Bristol-Myers' position in the lucrative as well as highly sought
after immuno-oncology space. We expect investor focus to remain on
updates regarding the high potential Opdivo. Opdivo is also being
studied in other oncology indications as well, such as, renal cell
carcinoma, head and neck cancer, glioblastoma and non-Hodgkin
Bristol-Myers carries a Zacks Rank #3 (Hold). Better-ranked stocks
in the health care sector include
The Medicines Co.
). Both the stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research?
Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report
BRISTOL-MYERS (BMY): Free Stock Analysis Report
MEDICINES CO (MDCO): Free Stock Analysis Report
BIOGEN IDEC INC (BIIB): Free Stock Analysis
MERCK & CO INC (MRK): Free Stock Analysis
To read this article on Zacks.com click here.