FDA Grants Breakthrough Therapy Tag to LLY's Ovarian Cancer Candidate

Eli Lilly and Company LLY announced that the FDA has granted a Breakthrough Therapy designation to its novel folate receptor alpha (FRα) antibody-drug conjugate (ADC), sofetabart mipitecan (LY4170156), for treating certain patients with platinum-resistant ovarian cancer.

The regulatory body has granted the Breakthrough Therapy designation to sofetabart mipitecan for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, who have received Roche’s Avastin (bevacizumab) and AbbVie’s Elahere (mirvetuximab soravtansine) before, if eligible.

The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when early clinical evidence suggests that a drug may significantly improve over existing treatments on one or more important clinical measures.

LLY’s Price Performance

In the past six months, shares of Lilly have rallied 36.6% compared with the industry’s increase of 23.6%.

More on the Latest FDA Tag for LLY’s Sofetabart Mipitecan

The FDA’s Breakthrough Therapy designation for sofetabart mipitecan was based on encouraging preliminary data from the phase Ia/b study. Updated data announced in October showed responses at all dose levels and across all FRα expression levels with sofetabart mipitecan, including in patients who progressed on prior treatment with Elahere.

The initial data also suggest a good tolerability profile of sofetabart mipitecan, with low rates of interstitial lung disease, peripheral neuropathy, alopecia and no significant eye-related toxicity.

The phase III FRAmework-01 study is currently evaluating sofetabart mipitecan as a monotherapy for treating patients with platinum-resistant ovarian cancer, and in combination with Avastin in patients with platinum-sensitive ovarian cancer.

Per the company, the latest Breakthrough Therapy designation and preliminary clinical results for sofetabart mipitecan across all FRα expression levels are promising and suggest it could become an important treatment option for the given patient population.

Besides ovarian cancer, sofetabart mipitecan is also being studied for other FRα-expressing solid tumors.

LLY’s Zacks Rank & Stocks to Consider

Eli Lilly currently has a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Alkermes ALKS, Immunocore IMCR and Krystal Biotech KRYS, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Alkermes’ 2026 earnings per share (EPS) have increased from $1.54 to $1.90. Shares of ALKS have gained 19.1% over the past six months.

Alkermes’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 4.58%.

Over the past 60 days, Immunocore’s loss per share estimates for 2026 have decreased from 97 cents to 90 cents. Shares of IMCR have lost 9.7% over the past six months.

Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 53.96%.

Over the past 60 days, estimates for Krystal Biotech’s 2026 EPS have risen to $8.49 from $8.34. KRYS stock has rallied 85.5% over the past six months.

Krystal Biotech’s earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 40.43%.

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

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