Artificial Intelligence | News | Insights | AiThority
[bsfp-cryptocurrency style=”widget-18″ align=”marquee” columns=”6″ coins=”selected” coins-count=”6″ coins-selected=”BTC,ETH,XRP,LTC,EOS,ADA,XLM,NEO,LTC,EOS,XEM,DASH,USDT,BNB,QTUM,XVG,ONT,ZEC,STEEM” currency=”USD” title=”Cryptocurrency Widget” show_title=”0″ icon=”” scheme=”light” bs-show-desktop=”1″ bs-show-tablet=”1″ bs-show-phone=”1″ custom-css-class=”” custom-id=”” css=”.vc_custom_1523079266073{margin-bottom: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}”]

Alkermes Receives Fda Fast Track Designation For Nemvaleukin Alfa In Combination With Pembrolizumab For The Treatment Of Platinum-resistant Ovarian Cancer

– Second Fast Track Designation for Nemvaleukin –

Alkermes plc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, in combination with pembrolizumab, an anti-PD-1 antibody, for the treatment of platinum-resistant ovarian cancer. The FDA previously granted Fast Track designation and Orphan Drug designation to nemvaleukin for the treatment of mucosal melanoma.

Recommended AI News: Orbis Systems Partners with Signzy to Expand Identity Verification Services to India

“This Fast Track designation in platinum-resistant ovarian cancer highlights the potential clinical utility of nemvaleukin in combination with pembrolizumab in this difficult-to-treat disease for which there is no approved immunotherapy and there remains significant need for new treatment options,” said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. “We are excited to initiate our planned ARTISTRY-7 phase 3 trial in platinum-resistant ovarian cancer, as we advance nemvaleukin toward potential registration and seek to help patients living with this disease.”

Related Posts
1 of 21,782

Recommended AI News: Orbis Systems Partners with Signzy to Expand Identity Verification Services to India

Fast Track is an FDA process designed to facilitate the development, and expedite the review, of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met. For more information on Fast Track designation, please visit the FDA’s website, available at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.

Recommended AI News: Ampliphi Launches New Platform To Help Organizations Seamlessly Accelerate the Circular Economy

[To share your insights with us, please write to sghosh@martechseries.com]

Comments are closed.