AMTAGVI Receives Accelerated FDA Approval for Advanced Melanoma

DENVER, Colo., Feb 16, 2024 (www.247marketnews.com)- Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) announced, a few minutes ago, that the U.S. Food and Drug Administration approved its AMTAGVI (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody and this indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

“The accelerated approval of AMTAGVI™ is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients. We are continuing our development efforts to address additional unmet medical needs in patients with solid tumor cancers, making our novel cell therapies available to more patients with melanoma and other types of cancers.”

IOVA is trading at $9.6056, down $0.2644 (-2.68%), on trading volume of 3,203,136 shares.

Its 52-week range is $3.21 to $10.31 and this news could help it set a new 52-week high.

“The approval of AMTAGVI™ offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients,” said Samantha R. Guild, J.D., President, AIM at Melanoma Foundation. “This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.”

Connect with 24/7 Market News @
www.247marketnews.com
X (formerly twitter)
Facebook

About 24/7 Market News

As a pioneer in digital financial market media, 24/7 Market News (24/7MN) is dedicated to the swift distribution of financial market news and information. 24/7 MN incorporates comprehensive corporate communications resources and tools to engage the investment community.

DISCLAIMER:
24/7 Market News (24/7MN) is a third-party publisher and online news dissemination service provider that produces regular sponsored and non-sponsored reports, articles, stock market blogs, and newsletters covering equities listed on the NYSE, NASDAQ, and micro-cap exchanges. 24/7MN holds no investment licenses and is NOT a financial advisory firm, investment adviser, analyst, or broker-dealer and does not undertake any activities that would require such registration. 24/7 MN is not affiliated with any company written about in this release and owns no shares of stock. 24/7MN’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities.
The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and based on publicly available information which is believed to be reliable.
The stocks and strategies discussed are simply ideas only and are in no way financial advice or recommendations. The author may or may not at any time be holding securities discussed. The author may or may not enter trades in the stocks mentioned. Some positions in mentioned stocks may already be held or are being adjusted or are simply examples, ideas or discussion topics. You are always trading at your own risk.

Cautionary Statement Regarding Forward Looking Information
Statements in this press release about the Company’s future and expectations other than historical facts are “forward-looking statements.” These statements are made on the basis of management’s current views and assumptions. As a result, there can be no assurance that management’s expectations will necessarily come to pass. These forward-looking statements generally can be identified by phrases such as “believes,” “plans,” “expects,” “anticipates,” “foresees,” “estimated,” “hopes,” “if,” “develops,” “researching,” “research,” “pilot,” “potential,” “could” or other words or phrases of similar import. Forward looking statements include descriptions of the Company’s business strategy, outlook, objectives, plans, intentions and goals. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements. This press release does not constitute an offer to sell or the solicitation of an offer to buy any security.

CONTACT:
24/7 Market News
[email protected]

NASDAQ and NYSE quotes and data are delayed 15 minutes unless indicated otherwise. Market data and exchange information are provided for informational purposes only and is not intended for trading purposes. Neither 24/7 Market News Editors, 247 Market News, or data and content providers shall be liable for any errors or omissions, delays, misquotes or other market information relayed in any press materials. You should Use Realtime data to conduct due diligence before investing or trading, and trading in any stock is risky you could lose all your money.