News from the FDA about treating and imaging ovarian cancer

RELEVANCE

Most relevant for: People with ovarian cancer..

It may also be relevant for:

people with platinum-resistant ovarian cancer
people with metastatic or advanced cancer

Relevance: Medium-High

Relevance rating details

New Drug Approval

ELAHERE (mirvetuximab soravtansine-gynx) was first approved by the in November 2022 under an accelerated approval program. Recently, additional data led the FDA to grant full approval of ELAHARE.

ELAHERE is used to treat adults with ovarian, fallopian or primary peritoneal cancer that tests positive for a known as FRα (folate receptor alpha) expression. The drug may be used to treat cancers that have become platinum resistant after one to three prior rounds of platinum chemotherapy treatments.

Of the 104 females who participated in the clinical trial and were treated with ELAHERE, 33 (about one-third) experienced complete or partial shrinkage of their tumors. On average in this study, the time without cancer growing was about 7 months.

ELAHERE prescribing information contains a boxed warning for ocular . Boxed warnings (formerly black box warnings) are the highest medication safety-related warnings assigned by the FDA.

Eye problems are common with ELAHERE and can be severe. These problems may include blurred vision, dry eyes, sensitivity to light, eye pain, or new or worsening vision changes. People who consider taking ELAHARE should have an eye exam, including a slit-lamp exam before they begin treatment with ELAHARE. A slit-lamp exam uses a special magnifying microscope with a bright light to examine the eye structures, including the cornea, iris, vitreous and retina for signs of cataracts, glaucoma and other eye conditions. The exam is not painful, but the eye drops used may be uncomfortable.

Why is this update important?

The FDA uses its Accelerated Approval Program to allow earlier approval of drugs that treat serious conditions and fulfill an unmet medical need. Drug companies must still conduct studies to confirm the benefit of drugs that have accelerated approval. If the studies support a benefit, the FDA grants full approval. If the study does not show that the drug provides a benefit, the FDA may remove the drug from the market.

ELAHERE was granted full approval because of study data that showed its benefit. People who have platinum-resistant ovarian cancer that tests positive for the biomarker FRα may be eligible for treatment with ELAHARE.

New Imaging Approval

Cytalux (pafolacianine), is a fluorescent dye given intravenously before cancer surgery to help surgeons better see malignant cells. Cytalux causes tumor cells to glow under fluorescent light. This helps the surgeon remove cancerous tissue while avoiding healthy tissue. Cytalux was first approved by the FDA in November 2021 for ovarian cancer.

A recent study reinforced the original FDA approval of Cytalux. In this study, Cytalux detected ovarian cancer in more than one-third of patients whose tumors would not have been detected under normal light or by physical touch. Without the use of Cytalux before surgery, these tumors would not have been completely removed. The study did not compare patients who received Cytalux and those who did not. The study did not examine overall survival in patients who received Cytalux. It is unknown if the improvement in imaging tumors with Cytalux will improve in patient outcomes.

Why is this update important?

Despite significant advances in maintenance chemotherapy for ovarian cancer, surgical removal of all the cancer, including microscopic disease (cancerous cells that are only visible under a microscope) is an important factor for overall survival. Limitations to the current surgical approach include visually looking for and feeling for small-sized tumors.

Cytalux may offer an important real-time benefit for surgeons. It potentially adds an additional measure of visibility in the operating room, which can help surgeons detect cancerous tissue that may have otherwise been missed. Additionally, Cytalux has been used to help surgeons visualize lung cancer tumors during surgery.

What does this mean for me?

If you develop platinum-resistant ovarian cancer, you may benefit from treatment with ELAHARE.

If you are newly diagnosed with ovarian cancer, ask your surgeon if Cytalux will be used to help identify ovarian cancer that is not visible or cannot be felt.

Reference

U.S. Food and Drug Administration (FDA). Drug trial snapshots: ELAHERE. FDA Drug Approvals and Databases; October 24, 2023.

U.S. Food and Drug Administration (FDA). Drug trial snapshots: Cytalux. FDA Drug Approvals and Databases; October 19, 2023.

To read more of FORCE’s XRAY articles on or about ovarian cancer click this link.

Additional Information

The FDA provides a podcast series called Drug Information Soundcast in Clinical Oncology (DISCO), offering up-to-date information on new product approvals, emerging safety information for cancer treatments and other current topics in cancer drug development. Listen to them on Apple Podcasts, Google Podcasts or Spotify.

You can listen to the FDA’s DISCO about the approval of ELAHERE here.

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 5/30/24

Questions To Ask Your Doctor

Am I a candidate for treatment with ELAHARE?
What are the most common side effects I can expect with ELAHARE?
Is Cytalux regularly used during surgery to remove ovarian cancer at this institution?
Am I a candidate for Cytalux during my ovarian cancer surgery?

Open Clinical Trials

Studies looking at PARP inhibitors and similar agents for treating people with ovarian cancer can be found here.

Updated: 07/09/2024

Peer Support

The following organizations offer peer support services for people with or at high risk for ovarian cancer:

FORCE peer support
- Our Message Boards allow people to connect with others who share their situation. Once you register, you can post on the Diagnosed With Cancer board to connect with others who have been diagnosed.
- Peer Navigation Program will match you with a volunteer who shares your mutation and situation.
- Private Facebook Group
- Virtual and in-person support meetings
- Join a Zoom community group meeting.
  - LGBTQIA
  - Men
  - American Sign Language
  - People of Color
National Ovarian Cancer Coalition
Ovarian Cancer Research Alliance
Clearity Foundation

Updated: 02/05/2022

Update: News from the FDA: New ovarian cancer treatment and imaging drug

RELEVANCE

Relevance: Medium-High

New Drug Approval

Why is this update important?

New Imaging Approval

Why is this update important?

What does this mean for me?

Reference

Additional Information

Questions To Ask Your Doctor

Open Clinical Trials

Peer Support

Knowledge Can Save Lives

Update: News from the FDA: New ovarian cancer treatment and imaging drug

RELEVANCE

Relevance: Medium-High

New Drug Approval

Why is this update important?

New Imaging Approval

Why is this update important?

What does this mean for me?

Reference

Additional Information

Questions To Ask Your Doctor

Open Clinical Trials

Peer Support

Related Resources

Knowledge Can Save Lives