TUKYSA Regimen Receives FDA Approval as Front-Line Maintenance Treatment for HER2+ Metastatic Breast Cancer
“Since its first approval in 2020, TUKYSA has become an important treatment for patients with second-line HER2+ metastatic breast cancer. Today’s FDA approval marks the next chapter for TUKYSA, bringing it into the front-line maintenance setting and offering patients a chemotherapy-free option that can help delay disease progression after initial treatment. This approval reflects Pfizer’s commitment to advancing therapies across the breast cancer treatment journey and delivering meaningful new options for people living with metastatic breast cancer.”, said Aamir Malik, Executive Vice President, Chief U.S. Commercial Officer, Pfizer.
Share:
More News
“Identifying recurrence of colorectal cancer before it becomes clinically apparent, when it is potentially much easier to treat, is one of the central challenges in developing breakthrough therapies that help to answer unmet medical needs for this setting,” said Philippe P. Calais, PharmD, Ph.D., chairman and CEO, TransCode Therapeutics. “Leveraging
“The improvement in progression-free survival is a defining moment for RYZ101 and for the patients we built this program around — people with advanced GEP-NETs whose cancer has progressed after Lu177-based therapy and who have few remaining options,” said Amreen Husain, MD, chief medical officer of RayzeBio. “This is the
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated, “The FDA’s decision to grant Fast Track Designation just nine days after submission is an encouraging milestone for opamtistomig and our first-line BTC program. We appreciate the FDA’s engagement and its recommendation to initiate discussions on the U.S. registration strategy
“PI3Kα is one of the most important, well-validated, and heavily pursued disease drivers in oncology, but its therapeutic potential has been constrained by wild-type PI3Kα-mediated toxicity and incomplete coverage of clinically relevant mutations,” said Rob Kania, Ph.D., Chief Executive Officer of KymaThera. “Our drug design objective from the outset was