Bristol-Myers Squibb Company (NYSE:BMY) announced that the FDA has approved Opdivo for the treatment of classical Hodgkin lymphoma (cHL) in patients who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation Adcetris (brentuximab vedotin).
Accelerated approval of Opdivo in the cHL indication was based on the overall response rate. This marks the first PD-1 inhibitor to be approved for a hematological malignancy.
However, the drug’s label will include a new Warning and Precaution, mentioning the risk of complications related to allogeneic HSCT following Opdivo therapy.
We note that Opdivo is currently approved in the U.S. for several indications – BRAF V600 wild-type unresectable or metastatic melanoma; BRAF V600 mutation-positive unresectable or metastatic melanoma; metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy; and advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. Moreover, a combination of Opdivo with Yervoy is approved for the treatment of patients with unresectable or metastatic melanoma.
We remind investors that last week, the combination of Opdivo and Yervoy was approved in the EU for the treatment of adults with advanced (unresectable or metastatic) melanoma.
Opdivo generated sales of $704 million in the first quarter of 2016.
According to the American Cancer Society, approximately 8,500 new cases of Hodgkin lymphoma (HL) will be diagnosed in 2016. As per the Lymphoma Research Foundation, cHL accounts for 95% of HL cases.
Bristol-Myers currently sports a Zacks Rank # 1 (Strong Buy). Other top-ranked stocks in the health care sector include SurModics, Inc. (NASDAQ:SRDX) , Retrophin, Inc. (NASDAQ:RTRX) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) . All these stocks carry the same Zacks Rank as Bristol-Myers.
BRISTOL-MYERS (BMY): Free Stock Analysis Report
SURMODICS (SRDX): Free Stock Analysis Report
RETROPHIN INC (RTRX): Free Stock Analysis Report
ANI PHARMACEUT (ANIP): Free Stock Analysis Report
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Bristol-Myers' Opdivo Wins FDA Nod For Additional Indication
Published 05/17/2016, 09:26 PM
Updated 07/09/2023, 06:31 AM
Bristol-Myers' Opdivo Wins FDA Nod For Additional Indication
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