FDA Accepts Roche's NDA Seeking Approval for Breast Cancer Drug

Roche RHHBY announced that the FDA has accepted its new drug application (NDA) for giredestrant, an investigational oral therapy, in combination with everolimus, for the treatment of adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated locally advanced or metastatic breast cancer following progression on prior endocrine therapy.

The FDA has set a target action date of Dec. 18, 2026.

Per RHHBY, the regimen could become the first and only oral selective estrogen receptor degrader (SERD) combination available in the post-CDK4/6 inhibitor setting if approved.

Over the past year, Roche’s shares have gained 43% compared with the industry’s growth of 12.1%.

More on FDA Acceptance of RHHBY’s NDA Filing

The NDA filing was supported by data from the phase III evERA breast cancer study, which demonstrated that giredestrant plus everolimus significantly improved progression-free survival compared with the standard endocrine therapy plus everolimus. The giredestrant/everolimus combination reduced the risk of disease progression or death by 44% in the overall intention-to-treat (ITT) population and 62% in patients with ESR1-mutated populations.

Median PFS was extended to 8.77 months in the ITT group and to 9.99 months in the ESR1-mutated population, compared with 5.49 and 5.45 months, respectively, in the control arm.

The overall survival data showed a positive trend in both the ITT and ESR1-mutated populations, with further follow-up ongoing.

The combination showed a manageable safety profile, with no adverse events observed.

evERA marked the first positive phase III outcome for giredestrant, followed by encouraging results from the phase III lidERA study in early-stage breast cancer.

Roche plans to submit lidERA data to global health authorities, including the FDA, shortly, with additional phase III data from persevERA in the first-line setting, expected in the first half of the year.

More on RHHBY’s Giredestrant

Giredestrant is an investigational, oral, potent next-generation selective estrogen receptor degrader and full antagonist designed to block estrogen and thereby slow or stop the growth of ER-positive breast cancer cells.

Roche is also evaluating giredestrant in an extensive clinical development program in five company-sponsored phase III studies that span multiple treatment settings and lines of therapy.

The successful development of giredestrant will boost RHHBY’s breast cancer franchise, as ER-positive breast cancer accounts for approximately 70% of cases diagnosed.

RHHBY’s Zacks Rank and Stocks to Consider

Roche currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY, Assertio Holdings ASRT and Castle Biosciences CSTL, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.72 to $4.00. HRMY shares have lost 14.7% over the past year.

Harmony Biosciences’ earnings beat estimates in two of the trailing four quarters but missed on the remaining occasion, with the average surprise being 7.20%.

Over the past 60 days, estimates for Assertio’s 2026 loss per share have narrowed from 30 cents to 28 cents. ASRT shares have lost 0.9% over the past year.

Assertio’s earnings beat estimates in one of the trailing four quarters and missed in the remaining occasions, with the average negative surprise being 35.21%.

Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 96 cents. CSTL shares have risen 15.2% over the past year.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 66.11%.

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This article originally published on Zacks Investment Research (zacks.com).

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