Novartis and Merck skin cancer drugs move through pipeline
pharmafile | August 20, 2015 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Merck, Novartis, Odomzo, basal cell carcinoma, keytruda, melanoma, pembrolizumab, skin cancer, sonidegib
Both Novartis and Merck have hit regulatory milestones with their skin cancer drugs in the EU and the US.
Novartis’ skin cancer drug Odomzo (sonidegib) has been signed-off by the European Commission, while in the US, Merck’s drug Keytruda (pembrolizumab) has been given a priority review by the FDA.
Odomzo is approved for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) who cannot have curative surgery or radiation therapy.
“We are pleased to have a new treatment option for European patients living with advanced basal cell carcinoma,” says Bruno Strigini, president of Novartis Oncology. “This milestone follows the recent approval of Odomzo in the US and is the latest example of our commitment to precision oncology and developing targeted treatments to address unmet needs.”
The EU approval of Odomzo is based on data from a Phase II study in patients with laBCC who are not open to local therapy or metastatic basal cell carcinoma (mBCC).
Meanwhile in the US, Merck’s cancer immunotherapy Keytruda (pembrolizumab) could have a first-line licence for melanoma by the end of the year as the FDA speeds up the review of the treatment.
The treatment teaches the body’s immune system to fight tumours has a licence for advanced or unresectable melanoma for patients who are no longer responding to other drugs. The drug is also under review for the treatment of certain lung cancers.
Dr Roger Perlmutter, president of Merck Research Laboratories, says: “Through our clinical programme for Keytruda we have accumulated substantial data on the role of our anti-PD-1 therapy in advanced melanoma. We look forward to the FDA’s review of each of these applications, and to delivering on our goal of helping patients with advanced melanoma to achieve long-term disease control and survival.”
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