Merck & Co., Gilead, and BMS Lead Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Merck & Co., Gilead Sciences, and Bristol-Myers Squibb.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday June 27, 2018 to Tuesday July 10, 2018.
FDA Grants Priority Review to Merck & Co.’s sBLA for Keytruda in Combination with Chemotherapy
The US Food and Drug Administration (FDA) has accepted for review a supplemental biologics license application (sBLA) for Merck & Co.’s Keytruda (pembrolizumab),an anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a treatment for metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression.
The FDA has granted priority review to this sBLA and has set a Prescription Drug User Fee Act, or target action, date of October 30, 2018.
Keytruda is one of Merck & Co.’s top-selling drugs with 2017 revenues of $3.8 billion. Keytruda is indicated for treating various cancers: unresectable or metastatic melanoma; locally advanced or metastatic urothelial carcinoma; head and neck cancer; classical Hodgkin lymphoma; certain forms of gastric cancer; and microsatellite instability-high cancer.
Source: Merck & Co.
EMA Advisory Council Recommends Gilead’s Yescarta for Two Types of Lymphoma
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has recommended a marketing authorization application for Yescarta (axicabtagene ciloleucel) from Kite Pharma, Gilead Sciences’ cell-therapy subsidiary, as a treatment for two types of lymphoma.
Specifically, Yescarta is being recommended as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy.
Axicabtagene ciloleucel was approved by the US Food and Drug Administration in October 2017 for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
Source: Gilead Sciences
EMA Advisory Council Recommends New Use for BMS’ Opdivo
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an expanded indication for Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab), an immuno-oncology drug, to include the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
Opdivo is approved to treat several cancers, including: unresectable or metastatic melanoma; wild-type unresectable or metastatic melanoma; metastatic non-small cell lung cancer; advanced renal cell carcinoma; classical Hodgkin lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; locally advanced or metastatic urothelial carcinoma; microsatellite instability high or mismatch repair deficient metastatic colorectal cancer; and hepatocellular carcinoma.
Source: Bristol-Myers Squibb
EC OKs Expanded Indication for BMS’ Sprycel in Leukemia
The European Commission (EC) has approved an expanded an indication for Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) to include treating children and adolescents with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase and a powder for oral-suspension formulation.
Sprycel received US Food and Drug Administration (FDA) approval in 2006 for treating adults with Ph+ CML in chronic phase who are resistant or intolerant to prior therapy including imatinib. At that time, Sprycel also received FDA approval for adults with Ph+ acute lymphoblastic leukemia who are resistant or intolerant to prior therapy. Sprycel is approved and marketed for these indications in more than 60 countries.
Sprycel is also an FDA-approved treatment for adults with newly diagnosed Ph+ CML-CP, and in November 2017, Sprycel received FDA approval for the expanded indication for treatment in pediatric patients with Ph+ CML-CP. The adult indication is approved in more than 50 countries.
Source: Bristol-Myers Squibb