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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.

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PharmaTimes  |  Jul 7, 2014

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Old Cancer Drug Gets Fresh Look

Old Cancer Drug Gets Fresh Look | Melanoma Dispatch | Scoop.it

"When Dave deBronkart was diagnosed with advanced kidney cancer in 2007, he learned about a treatment called high-dose interleukin-2 (IL-2) that fires up the body’s immune system to fight the disease. The response rate was not great — tumours shrank in only about 15% of patients. And as many as 4% of people died from the treatment. But some of those who responded survived for years or even decades."


Editor's note: IL-2 is an immunotherapy drug, meaning that it boosts a patient's own immune system to fight cancer. It and other new immunotherapies are showing promise for patients across many different cancer types.

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Nature  |  May 27, 2014

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Nature  |  May 27, 2014

Cancer Commons's curator insight, May 28, 2014 5:19 PM

Nature  |  May 27, 2014

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Anti-PD-1 Antibody MK-3475 Advances Into Multiple Tumor Types

Anti-PD-1 Antibody MK-3475 Advances Into Multiple Tumor Types | Melanoma Dispatch | Scoop.it

"Merck announced the signing of three separate clinical collaboration agreements to evaluate the potential of its investigational anti-PD-1 immunotherapy MK-3475 across multiple tumor types.  The agreements, of which financial terms were not disclosed, were signed through subsidiaries with Amgen Inc., Incyte Corporation, and Pfizer Inc.

"As part of the new collaborations, Merck will begin several clinical trials. In these phase I/II studies, MK-3475 will be explored in combination with axitinib in renal cell carcinoma, talimogene laherparepvec (T-VEC) in previously untreated advanced melanoma, the immunotherapy INCB24360 in previously treated metastatic recurrent non-small cell lung cancer (NSCLC), and PF-2566 in multiple cancer types. Separate from these collaborations, Merck announced that the safety and efficacy of MK-3475 monotherapy would be evaluated in a phase I “signal finding” study in 20 PD-L1-positive solid tumor types not previously studied."

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OncLive  |  Feb 7, 2014

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OncLive  |  Feb 7, 2014

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OncLive  |  Feb 7, 2014

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PD-1 Antibody Demonstrated Encouraging Activity in Metastatic Melanoma

PD-1 Antibody Demonstrated Encouraging Activity in Metastatic Melanoma | Melanoma Dispatch | Scoop.it

"Heavily pretreated patients with metastatic melanoma who received the humanized anti-PD-1 monoclonal antibody pidilizumab demonstrated encouraging rates of 12-month OS, according to results of a phase 2 study presented at the ASCO Annual Meeting.


“ 'Activity was previously seen [with pidilizumab] in two lymphoma populations in phase 2 studies,' researcher Michael B. Atkins, MD, deputy director of Georgetown-Lombardi Comprehensive Cancer Center in Washington, and professor of oncology and medicine at Georgetown University School of Medicine, said during a presentation. 'Correlative studies in those lymphoma populations supported a PD-1/PD-L1–linked mechanism of action, and importantly there was no change or an increase in PD-1–positive CD4 and CD8 lymphocytes and CD14 monocytes following the drug, excludingantibody-dependent cellular cytotoxicity of PD-1–positive cells as a consequence of therapy.' "


Editor's note: Pidilizumab is a new drug that that might benefit people with metastatic melanoma who have already been heavily treated. A recent clinical trial testing it in volunteer patients found some promising results, but further studies will be needed to see how to use pidilizumab most effectively, in terms of dosage and combining it with other drugs. Pidilizumab is an "anti-PD-1" immunotherapy, meaning that it interacts with a protein called PD-1 to boost a patient's own immune system to fight cancer. Learn more about immunotherapy treatments for melanoma at our Need to Know blog.

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Healio  |  Jun 24, 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.

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Cancer Network  |  May 21, 2014

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Cancer Network  |  May 21, 2014

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Cancer Network  |  May 21, 2014