Gilead Sciences is bolstering its oncology offering acquiring Immunomedics in a deal that values the latter at $21 billion.
The agreement will provide Gilead with Trodelvy (sacituzumab govitecan-hziy), a first-in-class Trop-2 directed antibody-drug conjugate (ADC) that was granted accelerated approval by FDA in April for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.
Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support full approval of Trodelvy in the US in the fourth quarter of 2020 (when the deal is anticipated to close). Immunomedics is also on track to file for regulatory approval in Europe in the first half of 2021.
Beyond mTNBC, Trodelvy is also being studied in an ongoing Phase 3 trial in third line HR+/HER2- breast cancer and a registrational Phase 2 study in bladder cancer.
Additional ongoing studies are evaluating the potential of Trodelvy as a treatment for non-small cell lung cancer and other solid tumour types.
Trodelvy is being studied as both a monotherapy and in combination with checkpoint inhibitors and other non-immuno-oncology products by Immunomedics and independent investigators.
“This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio,” said Daniel O’Day, Chairman and CEO of Gilead Sciences
“Trodelvy is an approved, transformational medicine for a form of cancer that is particularly challenging to treat. We will now continue to explore its potential to treat many other types of cancer, both as a monotherapy and in combination with other treatments.”