Update: Promising FDA updates in ovarian cancer

RELEVANCE

Most relevant for: People with advanced ovarian, fallopian tube or primary peritoneal cancer.

It may also be relevant for:

• people with metastatic or advanced cancer
• people with ovarian cancer

Relevance: Medium-High

Research Timeline: Human Research

More rating details

What is this update about?

On February 10, 2026, the FDA approved the immunotherapy drug Keytruda (pembrolizumab ) for use with the chemotherapy paclitaxel, with or without Avastin (bevacizumab). This approval is for people with platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who meet all of the following circumstances:

• Have a cancer that no longer responds to platinum-based chemotherapy (platinum resistant)
• Received one or two prior courses of treatment
• Have a tumor that tests positive for a biomarker called PD-L1

The FDA also approved a companion test to check ovarian cancer tumors for the PD-L1 marker.  The test helps to identify people who might benefit from Keytruda.

Keytruda

Keytruda is a type of immunotherapy known as an immune checkpoint inhibitor. These drugs help the body’s immune system find and destroy cancer cells. Keytruda is already FDA-approved to treat many types of cancer, including breast, colorectal, endometrial, esophageal, kidney, lung and melanoma. It is also approved across all types of cancers that have tumors with biomarkers known as MSI-High (microsatellite instability) or TMB-High (tumor mutational burden). Keytruda can be given as an injection in the vein (IV) or under the skin.

Why is this update important?

Treatment options for platinum-resistant ovarian cancer are limited. The expanded approval of Keytruda adds a new option for some patients with ovarian cancer that no longer responds to platinum chemotherapy. This approval was based on results from a clinical trial called KEYNOTE‑B96.

KEYNOTE-B96

Keynote-B96 was a large, international study that enrolled 643 participants. Participants had platinum-resistant ovarian, fallopian tube or primary peritoneal cancer that had progressed or returned after one or two prior courses of treatment. At least one of these previous treatments included platinum chemotherapy. Participants were randomly assigned to one of two treatment groups:

• Group 1 received paclitaxel chemotherapy with or without Avastin.
• Group 2 received paclitaxel with or without Avastin and Keytruda.

People in the study with PD-L1 positive cancers who received Keytruda did better than those who did not receive it. 

People in the group that received Keytruda survived an average of 1 month longer without their cancer coming back  (progression-free survival). They also lived 4 months longer (overall survival) than people who did not receive Keytruda.

On average, people who received Keytruda:

• lived about 8 months before their cancer grew or returned, compared to about 7 months for those who did not receive Keytruda.
• lived about 18 months overall, compared to about 14 months for those who did not receive Keytruda. 

Side effects of Keytruda

In the Keynote-B96 study, the side effects of Keytruda were similar to those already reported in previous studies and from the use of Keytruda for other cancers. The most common side effects listed on the FDA label include:

• fatigue
• rash
• fever
• mouth sores
• cough or difficulty breathing
• joint or muscle pain
• low thyroid hormone
• urinary tract infection
• decreased appetite, nausea, vomiting, diarrhea, constipation, weight loss
• hand-foot syndrome (redness, swelling, pain or numbness in the hands or the feet)

The most serious side effects listed are immune-related (autoimmune). These happen when the immune system attacks healthy cells. Although these effects may be reversible, some can be severe. Symptoms depend on which organs are attacked. Some of the more common organs that may be affected include: 

• colon
• kidneys
• liver
• lungs
• adrenal glands
• pancreas (can lead to diabetes)
• pituitary gland
• thyroid
• skin

What does this mean for me?

If you have platinum-resistant ovarian cancer and you have already received one or two courses of chemotherapy, your doctor can order a test to see if your tumor is PD-L1 positive. This test can help determine whether Keytruda may be an option for your treatment. Keytruda may help some people live longer or extend the time until their cancer comes back or grows. If you are treated with Keytruda, talk with your medical provider about possible side effects, how they can be managed and how treatment may affect quality of life.

Reference: FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. U.S. Food and Drug Administration. Published February 10, 2026. Accessed February 26, 2026.

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

Two drugs receive FDA Breakthrough Therapy designation

Breakthrough Therapy designation is an FDA process that speeds up the development and review of drugs for serious or life‑threatening conditions when early clinical results suggest the drug may work much better than existing treatments.

Recently, the FDA granted Breakthrough Therapy designation to two new research drugs for platinum-resistant ovarian cancer. Both drugs belong to a category of targeted therapies known as antibody–drug conjugates (ACD). These treatments are designed to deliver chemotherapy directly to cancer cells.

In September 2025, the FDA granted Breakthrough Therapy status for the drug raludotatug deruxtecan (also called R-DXd). This drug targets tumors that express a protein biomarker called CDH6. The R-DXd therapy is being studied for people with platinum-resistant ovarian, primary peritoneal or fallopian tube cancers that progressed after treatment with Avastin (bevacizumab). A large, international clinical trial is now open and enrolling participants.

In January 2026, another drug called sofetabart mipitecan also received Breakthrough Therapy status. This drug targets a biomarker on ovarian cancer cells called folate receptor alpha (FRα). This treatment is being studied in people with platinum‑resistant and platinum-sensitive ovarian cancer and in people who were previously treated with a similar drug called mirvetuximab soravtansine (Elahere). You can read our XRAY review on Elahere. A large, international phase 3 clinical trial is now open and enrolling participants.

What does this mean for me?

If you have been diagnosed with ovarian cancer and your cancer did not respond to treatment or came back, ask your doctor if you might benefit from participating in a clinical research study.

References:

Merck & Co., Inc.; Daiichi Sankyo. FDA grants Breakthrough Therapy designation to raludotatug deruxtecan for CDH6‑expressing platinum‑resistant ovarian and related cancers. Press release. September 15, 2025. Accessed February 26, 2026.

Eli Lilly and Company. Lilly’s sofetabart mipitecan receives U.S. FDA’s Breakthrough Therapy designation for the treatment of certain patients with platinum‑resistant ovarian cancer. Press release. January 20, 2026. Accessed February 26, 2026.

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

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posted 3/09/26