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Japan Approves World's First PD-1 Drug, Nivolumab

Japan Approves World's First PD-1 Drug, Nivolumab | Melanoma Dispatch | Scoop.it

"Ono Pharmaceutical Co has become the first company in the world to get an approval for a PD-1 checkpoint inhibitor, as regulators in Japan gave the green light to nivolumab, developed with Bristol-Myers Squibb, as a treatment for melanoma.

"The drug will be marketed as Opdivo for unresectable melanoma although Ono noted that because of the very limited number of patients treated with nivolumab in Japanese clinical trials, the firm is required to perform a 'post-marketing use-results survey covering all cases until data on a certain minimum number of patients have been accumulated'."


Editor's note: The drug nivolumab is an immunotherapy, meaning that it boosts a patient's own immune system to fight cancer. Nivolumab is a specific kind of immunotherapy drug known as a "PD-1 checkpoint inhibitor," since it works by releasing a protein "brake" on the immune system called PD-1. Researchers testing the drug in volunteer patients have found promising results, and Japan has now given the world's first approval to nivolumab, permitting doctors across the country to prescribe it to people with unresectable melanoma.

Cancer Commons's insight:

PharmaTimes  |  Jul 7, 2014

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FDA Grants Merck’s Anti-PD1 Antibody Priority Review

FDA Grants Merck’s Anti-PD1 Antibody Priority Review | Melanoma Dispatch | Scoop.it

"The FDA has granted Merck’s anti-PD1 antibody MK-3475 a priority review designation for the treatment of unresectable or metastatic melanoma in patients who have previously been treated with ipilimumab. Priority review status is reserved for drugs considered to offer a significant improvement in the safety or efficacy of the treatment of a serious condition. It will shorten the drug’s FDA review period from 10 months to 6 months."


Editor's note: MK-3475 is an immunotherapy drug that works by boosting a patient's own immune system to fight cancer. Once it is approved by the FDA for unresectable or metastatic melanoma, doctors in the U.S. will be able to prescribe it to their patients outside of the clinical trial system.

Cancer Commons's insight:

Cancer Network  |  May 21, 2014

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Cancer Network  |  May 21, 2014

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Cancer Network  |  May 21, 2014

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NICE Proposes Ipilimumab as a First Treatment for Advanced Skin Cancer

NICE Proposes Ipilimumab as a First Treatment for Advanced Skin Cancer | Melanoma Dispatch | Scoop.it

"People with advanced skin cancer should be able to receive ipilimumab as a first treatment, the National Institute for Health and Care Excellence (NICE) proposes.


"In final draft guidance, NICE recommends that the drug ipilimumab (also called Yervoy and manufactured by Bristol-Myers Squibb Pharmaceuticals Limited) is made available on the NHS as a first-line treatment for patients with advanced malignant melanoma which is either unresectable (when the full tumour cannot be removed) or metastatic (the cancer has spread to other parts of the body).


"Sir Andrew Dillon, NICE chief executive, said: 'We already recommend ipilimumab as a second-line treatment and so we are pleased to be able to propose extending that recommendation to first line treatment too.' "


Editor's note: The UK's public healthcare system is required to provide funding for treatments recommended by NICE. To learn more about targeted melanoma drugs like ipilimumab, read The Basics.

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NICE  |  Jun 12, 2014

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UPDATE 1-EU Agency Backs Approval of New GlaxoSmithKline Melanoma Drug

"GlaxoSmithKline's melanoma drug Mekinist - one of several drugs being sold to Novartis under an asset swap deal - has been recommended for approval by European regulators.


"The European Medicines Agency (EMA) said on Friday its experts had backed the drug, also known as trametinib, as a treatment for unresectable or metastatic melanoma in patients with a mutation of a gene known as BRAF."

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Reuters  |  Apr 25, 2014

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