The pharmaceutical company Eli Lilly recently received approval from the US Food and Drug Administration with a Breakthrough Therapy Designation for a new drug called sofetabart mipitecan was awarded. This designation is only awarded if an active substance shows initial indications that it could deliver significantly better results in a serious disease than previously available therapies.

What is Sofetabart mipitecan?

Sofetabart mipitecan is a so-called antibody-drug conjugate (ADC) that specifically targets the folic acid receptor alpha (FRα) on tumor cells and releases a chemotherapy substance there. This receptor is strongly present in many ovarian tumors, which should allow the drug to have a targeted effect.
Previous results from early studies, which were presented at major cancer congresses such as ASCO 2025 and ESMO 2025, showed a tumor response in patients who had previously received standard therapies such as bevacizumab or mirvetuximab soravtansine. The data to date also indicate that side effects are manageable and that severe lung problems, nerve damage or severe eye damage rarely occurred.

What does the FDA designation mean?

The Breakthrough Therapy Designation is intended to accelerate the development process and enable earlier discussions with authorities. Although it is not a sure indication of approval, it does mean that the results to date are so promising that faster development and testing seems sensible.

Phase 3 study FRAmework-01 to start soon in Germany!

Based on these positive interim results, Lilly has initiated the phase 3 study called FRAmework-01 has been started. In this trial, sofetabart mipitecan is being investigated in patients with platinum-resistant ovarian cancer (PROC) as a single therapy patients with platinum-sensitive ovarian cancer (PSOC) in combination with bevacizumab.
The start of the trial in Germany is planned for spring 2026. spring 2026 and offers patients the opportunity to participate in an ongoing Phase 3 trial, provided they meet the inclusion criteria (e.g. diagnosis of a platinum-sensitive or platinum-resistant tumor).

Sofetabart mipitecan is a promising drug that could be effective in difficult-to-treat, platinum-resistant ovarian cancer, especially in tumors that no longer respond to other treatments, and is therefore a potential new therapeutic option.

The new Phase 3 study FRAmework-01 offers the opportunity to participate in an international study in Germany before approval is granted at a later date. As soon as the study starts, you will find further information on our study portal!

Source: Press release from Lilly (the article is in English)