FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation
Genentech's Inavolisib has received Breakthrough Therapy Designation from the FDA for treating advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. This designation is expected to expedite the development and review process, potentially bringing the treatment to market faster. Alvotech announced participation in the upcoming BofA Securities Healthcare Conference 2024 on May 14-15 in Las Vegas, where its management team will meet with investors.
- FDA Breakthrough Therapy Designation can expedite the development and review process for Inavolisib.
- Targeting advanced HR-positive, HER2-negative breast cancer with a PIK3CA mutation addresses a significant medical need.
- Participation in BofA Securities Healthcare Conference 2024 provides Alvotech with an opportunity to engage directly with investors.
- The designation does not guarantee final FDA approval.
- The treatment is still under development, which involves inherent risks and uncertainties.
- Financial implications of R&D and clinical trials could impact Alvotech's short-term financial performance.
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that members of management would be participating in the upcoming BofA Securities Healthcare Conference 2024, which will be held on May 14-15, 2024 in Las Vegas, NV.
Members of Alvotech’s management team will be attending the conference and hosting one-on-one meetings with investors.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech has launched two biosimilars. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, Senior Director
alvotech.ir@alvotech.com
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