Gilead Sciences and Immunomedics have announced they have entered into a definitive agreement whereby Gilead will acquire Immunomedics for approximately $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 the 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 later this year. The company is also on track to file for regulatory approval in Europe in the first half of 2021.

In the Phase III ASCENT study, which was halted early due to efficacy based on the unanimous recommendation of the independent Data Safety Monitoring Committee, Trodelvy significantly improved progression-free survival and overall survival in previously treated patients with advanced mTNBC.

Beyond mTNBC, Trodelvy is also being studied in an ongoing Phase III trial in third line HR+/HER2- breast cancer and a registrational PhaseII 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 tumor types.

“This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio. 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,” said Daniel O’Day, Chairman and CEO, Gilead Sciences.

                                                                                                                    From CPhI Online