Rigel Pharmaceuticals has entered into an exclusive global licensing agreement with Arvinas and Pfizer for VEPPANU™ (vepdegestrant), the first FDA-approved oral PROTAC therapy for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer.
VEPPANU demonstrated positive Phase 3 VERITAC-2 clinical trial results, showing a median progression-free survival (mPFS) of 5.0 months compared to 2.1 months for fulvestrant in patients with ESR1-mutated metastatic breast cancer. The therapy was generally well tolerated and reduced the risk of disease progression or death by 43%.
The FDA approved VEPPANU on May 1, 2026, for adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer following at least one line of endocrine therapy. The treatment was also recently added to the latest NCCN Clinical Practice Guidelines for Breast Cancer as a Category 2A treatment option.
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Under the agreement terms, Arvinas and Pfizer will receive an upfront payment of $70 million and an additional $15 million upon completion of certain transition activities. They are also eligible for up to $320 million in future regulatory and commercial milestone payments, along with tiered royalties on global sales.
Rigel stated that VEPPANU will become its fourth commercial product and a major focus of its long-term growth strategy. The company will lead U.S. commercialization efforts while retaining global rights to sublicense the therapy outside the U.S.
“Our transformational growth strategy took a significant step forward today as we plan to enter a targeted segment of the sizable breast cancer market, focused on patients with limited treatment options following progression on endocrine therapy,” said Raul Rodriguez, president and CEO of Rigel. “With its novel mechanism of action designed to address a key driver of resistance, VEPPANU represents a compelling treatment option within this setting.”
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“The ER+/HER2- patient population is the most prevalent breast cancer subtype, where treatment with endocrine therapies is the current standard of care,” said Erika Hamilton, Chief Development Officer at Sarah Cannon Research Institute and principal investigator of the VERITAC-2 trial. “Vepdegestrant provides a much-needed new treatment option for physicians that can fill a critical gap in care for patients with breast cancer.”
