Bristol Myers' Opdivo - A Pipeline In Itself...

(RTTNews) - Bristol-Myers Squibb Co.'s (BMY) immuno-oncology agent Opdivo has been greenlighted by the FDA for yet another indication - this time, it is an accelerated approval for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after prior therapies like autologous stem cell transplant and Seattle Genetics' Adcetris.

The approval was based on data from the company's phase II CheckMate -205 and phase I CheckMate -039 trials. Opdivo produced a 65% objective response rate, with 58% partial remission and 7% complete remission in adults with relapsed or refractory classical Hodgkin lymphoma. The median time-to-response was 2.1 months and estimated median duration of response was 8.7 months.

Classical Hodgkin's lymphoma, or cHL is the most common type of Hodgkin lymphoma, accounting for 95% of cases. Patients with cHL have an abnormal type of B lymphocyte called Reed-Sternberg cells, in their lymph nodes.

The approval of Opdivo for cHL is the eighth approval in less than two years.

Opdivo received its first FDA approval in December 2014 for the indication of unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma which no longer responds to other drugs.

The FDA expanded the approved use of Opdivo as a single agent to treat lung cancer in March 2015; in combination with Yervoy to treat BRAF V600 wild-type unresectable or metastatic melanoma and as a single agent to treat advanced lung cancer in October 2015; as a single agent to treat advanced renal cell carcinoma, a form of kidney cancer, and as a single agent to treat BRAF V600 wild-type unresectable or metastatic melanoma in November 2015, and combination with Yervoy to treat BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma in January 2016.

Opdivo works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body's immune cells and some cancer cells). Blockading this pathway helps the body's immune system fight the cancer cells.

Including the U.S., the European Union and Japan, the drug has regulatory approval in 46 countries.

Opdivo generated global sales of $942 million in 2015. With expanding indications, the drug logged sales of $704 million in the first quarter of 2016.

After all, finding new uses for an old drug is one surefire way to boost sales!

BMY closed Tuesday's trading at $71.21, down 2.22%.