FDA Approved Elahere, To Treat Adult Patients With Frα Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, Or Peritoneal Cancer. 

FDA Approval

On November 14, 2022, the FDA granted accelerated approval to Elahere (mirvetuximab soravtansine-gynx) for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer. The approval was based on an increase in the proportion of patients achieving partial or complete response (PPR) and a duration of response (DOR) greater than or equal to 6 months. Elahere is manufacture by the company called ImmunoGen, Inc, available as a lyophilized powder for intravenous infusion after reconstitution and dilution. 

Indication

Elahere is indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer. The FDA approval is based on an increase in the proportion of patients achieving partial or complete response (PPR) and a duration of response (DOR) greater than or equal to 6 months.

FRα-Positive:

• FRα stands for Folate Receptor alpha. It’s a protein found on the surface of many cells, including cancer cells.
• Positive means the cancer cells have a high amount of FRα on their surface.
• FRα plays a role in transporting folate, a nutrient needed for cell growth. Cancer cells often need more folate than normal cells, so targeting FRα can be a way to stop their growth.

Platinum-Resistant:

• Platinum refers to chemotherapy drugs like cisplatin and carboplatin, commonly used to treat ovarian cancer.
• Resistant means the cancer cells have become resistant to the effects of platinum drugs. This can happen after repeated treatment with platinum drugs.

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer:

These are three different types of cancer that can originate from the same tissue in the female reproductive system.

• Epithelial ovarian cancer is the most common type of ovarian cancer.
• Fallopian tube cancer starts in the fallopian tubes, which connect the ovaries to the uterus.
• Primary peritoneal cancer starts in the peritoneum, the lining of the abdomen and pelvis.

Together, FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer describes a specific type of cancer that has:

• A high level of FRα on the cancer cells.
• Become resistant to platinum drugs.
• Originates from the lining of the ovaries, fallopian tubes, or peritoneum.

This type of cancer is typically aggressive and difficult to treat. However, recent advances in targeted therapies, such as mirvetuximab soravtansine-gynx (Elahere), offer new hope for patients with this condition.

Mechanism

Elahere operates by precisely targeting cancer cells that express the folate receptor alpha (FRα). It utilizes an anti-FRα antibody-drug conjugate (ADC), combining the Globo H 2 antibody with the cytotoxic payload monomethyl auristatin E. Upon entering FRα-positive cancer cells, the payload is released, inducing DNA damage and resulting in the demise of tumor cells. This mechanism selectively targets cancer cells while minimizing harm to healthy cells.

Dosage Information

Elahere injection is administered as an intravenous infusion. 

• Recommended Dose:

The recommended dose of ELAHERE is 6 mg/kg adjusted ideal body weight. Administer this as an intravenous infusion every 3 weeks until disease progression or if unacceptable toxicity occurs.

• Premedication Protocols:

Prior to ELAHERE infusion, premedicate with a corticosteroid, antihistamine, and antipyretic to manage potential reactions.

• Additional Premedication Steps:

Supplement premedication with an antiemetic, ophthalmic topical steroids, and lubricating eye drops to enhance patient comfort and manage specific side effects.

Drug Interactions

There is limited information available on drug interactions with Elahere. When using ELAHERE along with strong CYP3A4 inhibitors, it’s important to keep a close eye for any possible side effects or reactions.

Pregnancy Considerations:

ELAHERE could be harmful to a developing baby because it contains a substance called DM4, which can affect cells that are actively dividing. If you’re a woman who can have a baby, it’s important to check if you’re pregnant before using ELAHERE. While using ELAHERE, make sure to use effective birth control. If you become pregnant while using ELAHERE, it’s crucial to understand and discuss the possible risks.

Lactation Advisory:

Information regarding the presence of mirvetuximab soravtansine-gynx in human milk and its impact on the breastfed child is currently unavailable. To mitigate potential serious adverse reactions, discourage breastfeeding during ELAHERE treatment and for one month following the last dose.

Pregnancy Testing and Contraception:

Conduct a pregnancy test for females of reproductive potential prior to initiating ELAHERE. Emphasize the importance of effective contraception throughout ELAHERE treatment and for seven months post the final dose.

Pediatric Use:

The safety and efficacy of ELAHERE have not been validated for pediatric patients.

Geriatric Considerations:

People aged 65 years and older experience ELAHERE in a way similar to younger individuals, with no notable differences in how well it works or its safety. ELAHERE’s behavior in the body isn’t significantly influenced by age.

Renal Impairment:

Patients with mild to moderate renal impairment (CLcr 30 to 90 mL/min) do not require ELAHERE dosage adjustments. The influence of severe renal impairment (CLcr 15 to < 30 mL/min) or end-stage renal disease on ELAHERE remains unknown.

Hepatic Impairment:

Refrain from administering ELAHERE to patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN). For those with mild hepatic impairment (total bilirubin≤ULN and AST >ULN or total), ELAHERE dosage adjustment is unnecessary.

Before starting the treatment, if is advised to inform you health provider about all the preexisting condition. Healthcare providers should consult the prescribing information and any relevant interaction checker tools before administering Elahere to these populations.

Side Effects

Common side effects of Elahere, affecting more than 20% of individuals, encompass issues like vision problems, fatigue, elevated liver enzyme levels, nausea, abdominal pain, and more. Additionally, Elahere may lead to infusion-related reactions, causing symptoms like fever and chills. While severe side effects are uncommon, they may include complications such as low platelet count, lung inflammation, eye inflammation, and nerve issues.

How To Buy Elahere Online? 

Those looking to obtain Elahere may need to go through the process of importing it, which involves navigating complex rules. Sansfro Health, a pharmaceutical procurement firm, is set up to help import the medication while ensuring authentic costs.

For details on Elahere price in India and how to import it, contact the Patient Assistance Team at(+91) 9315705373 or via email at help@sansfro.com. Sansfro Health aims to streamline the import process and provide correct pricing data. You can also use Sansfro Health’s services to purchase Elahere online and have it shipped from overseas. Their expertise handles the regulations involved with importing pharmaceuticals.

In summary, Elahere (mirvetuximab soravtansine-gynx) demonstrates a promising and targeted approach to cancer treatment, showcasing potential advancements in efficacy and reduced side effects. Its precision in targeting folate receptor alpha (FRα) positive cancers marks a notable stride in the evolving field of oncology, offering hope for improved outcomes in the fight against such cancers.

Reference:

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761310s000lbl.pdf
2. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-elahere-mirvetuximab-soravtansine-gynx-fra-positive-platinum 
3. https://www.drugs.com/elahere.html