Just days ago, Sanofi sent its oral selective estrogen receptor degrader (SERD) for breast cancer to the trash can. But over in Italy, a biotech is plodding forward with its own candidate, with the EU beginning a regulatory review.
The news for Menarini comes a few days after the FDA accepted elacestrant for priority review and placed a due date of Feb. 17, 2023, on the decision. Now, an application for the SERD has been validated by the European Medicines Agency for patients with second-line and third-line ER+/HER2- advanced or metastatic breast cancer. The validation means that the agency is kicking off its formal review.
Menarini expects the EU decision to arrive in the second half of 2023. The application was supported by data from a phase 3 study that found elacestrant improved progression-free survival compared to standard of care. The company also zeroed in on a subpopulation with a certain gene mutation that could indicate those who would benefit more from the therapy.
The smaller Italian company has succeeded where the Big Pharmas have failed. Sanofi announced Wednesday that it would scrap its oral SERD amcenestrant after a final phase 3 fail. Roche’s giredestrant similarly missed the mark in a phase 2 study in April.
And while AstraZeneca has the standard of care in the intramuscular SERD Faslodex, the company is behind in developing an oral option called camizestrant, which is in phase 2 and 3 study. Eli Lilly also has imlunestrant in a phase 3 trial.
In the wake of Sanofi’s decision to bid adieu to its SERD strategy, a negative perception now hangs over others in the class, SVB Securities analysts said Wednesday.
But Menarini’s candidate is the only one to succeed in a pivotal trial so far. The company indicated plans to study elacestrant in earlier lines of treatment for breast cancer patients with certain mutations.
Elacestrant is being developed with Radius Health.