Elacestrant hydrochloride

The FDA on Thursday approved Eli Lilly’s imlunestrant, an oral SERD, to treat patients with a certain kind of breast cancer. The drug will be branded as Inluriyo and is approved for all adult, second-line patients with ER-positive, HER2-negative breast cancer. Patients must also have a mutation of the ESR1 gene. Inluriyo will cost $22,500 for a 28-day regimen, which equals about $293,300 annually, a spokesperson told Endpoints News . Oral SERDs, or selective estrogen receptor degraders, are a relatively new class of medicine being tested in multiple breast cancer settings. They are typically given to patients who develop resistance to endocrine therapy. Biopharma companies have worked to develop oral SERDs to improve on the first generation of injectable SERDs, the first of which (AstraZeneca’s Faslodex) was approved in 2002. The first oral SERD was approved in 2023, a drug called Orserdu from Menarini Group and its subsidiary Stemline Therapeutics. Orserdu is indicated for the same kind of breast cancer as Inluriyo, but the patient population is limited to postmenopausal women and adult men. Inluriyo was approved based on Phase 3 data showing it reduced the risk of progression or death in ESR1-mutant patients by 38% versus standard of care. Progression-free survival was 5.5 months versus 3.8 months in the control arm. Notably, that study showed Inluriyo did not make a difference in overall trial population — ER-positive, HER2-negative breast cancer patients both with or without ESR1 mutations — though that was not an obstacle for approval. But the path to approval has not been smooth for every oral SERD. Programs from Sanofi and Roche each failed mid-stage trials in breast cancer back in 2022, though they’re still being tested in other forms of the disease. This week, Roche announced a successful Phase 3 study for its drug giredestrant in a patient population that has thus far eluded other drugmakers. Other oral SERDs remain in development, such as AstraZeneca’s camizestrant. At ASCO earlier this year, AstraZeneca showed off data from a unique trial where patients switched to camizestrant mid-study. Lilly is still testing Inluriyo in the adjuvant setting and in combination with another of its cancer drugs, Verzenio. A trial arm testing the combo regimen in the same Phase 3 trial was more successful in all-comers, achieving a 43% cut in the risk of progression or death versus the SERD alone. Inluriyo’s label comes with a warning and precaution for embryo-fetal toxicity. Editor’s note: This article has been updated to include Inluriyo’s pricing information and to correct that it was approved only as a monotherapy, not in combination with a CDK4/6 inhibitor.

The evERA trial only covers a slice of what Roche sees as a multibillion-dollar opportunity. \n Roche has reported a phase 3 win for its oral selective estrogen receptor degrader (SERD), bouncing back from an earlier setback to deliver data that could support filings for approval in breast cancer.The candidate, giredestrant, contributed to a downturn in excitement about oral SERDs in 2022. That year, giredestrant failed a midphase test and Sanofi’s rival asset amcenestrant flunked a pivotal trial. The field has shifted again since then, with Menarini’s Orserdu coming to market in second-line patients and AstraZeneca’s camizestrant improving outcomes in first-line patients with emergent ESR1 mutations.Roche’s calendar for 2025 and 2026 includes data drops that will inform whether giredestrant finds a place in the treatment arsenal. The drugmaker shared data from one of the trials Monday, reporting that a phase 3 study in a previously treated population of breast cancer patients met its co-primary endpoints.The evERA trial enrolled people with ER-positive, HER2-negative locally advanced or metastatic breast cancer who had previously received a CDK 4/6 inhibitor and endocrine therapy. Patients received the all-oral combination of giredestrant and everolimus or standard of care.  The giredestrant combination was associated with better progression-free survival than standard of care in both the intention-to-treat and ESR1-mutated populations, achieving the co-primary endpoints of the trial. Overall survival data were immature as of the data cutoff but trending in favor of the study drug. Follow-up is continuing to the next analysis.Roche said the study enriched for ESR1-mutated patients above the natural prevalence. The company is yet to disclose what proportion of patients had the mutation or say how the drug candidate performed in people with ESR1-wild-type breast cancer. Evidence of efficacy outside of people with ESR1 mutations could expand the market opportunity for giredestrant and other oral SERDs.The evERA trial only covers a slice of what Roche sees as a multibillion-dollar opportunity. Roche is closing in on results from trials that will have a bigger impact on the prospects of giredestrant, with data from the first-line persevERA and adjuvant lidERA studies due in 2026.