Advertisement Banner
  • Home
  • News
  • Medicine
  • Health Tech
  • Health Living
  • Contact
  • Privacy Policy
No Result
View All Result
  • Home
  • News
  • Medicine
  • Health Tech
  • Health Living
  • Contact
  • Privacy Policy
No Result
View All Result
HealthNews
No Result
View All Result
Home Health Tech News

FDA approves Enhertu for HER2-low breast cancer

admin by admin
August 5, 2022
in News


August 05, 2022

2 min read




ADD TOPIC TO EMAIL ALERTS

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

The FDA approved fam-trastuzumab deruxtecan-nxki for treatment of certain patients with unresectable or metastatic HER2-low breast cancer.

The approval — the first for a targeted therapy to treat HER2-low breast cancer — applies to patients who received prior chemotherapy in the metastatic setting, or those whose disease progressed during or within 6 months of adjuvant chemotherapy.

Infographic showing OS benefit with Enhertu

Fam-trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) is a novel antibody-drug conjugate with three components: a humanized anti-HER2 immunoglobulin G1 monoclonal antibody with the same amino acid sequence as trastuzumab (Herceptin, Genentech); a topoisomerase 1 inhibitor payload; and a tetrapeptide-based cleavable linker.

The agent already had been approved in the United States for treatment of adults with metastatic HER2-positive breast cancer who received prior anti-HER2-based therapies, as well as adults with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma who received a prior trastuzumab-based regimen.

Approximately 85% of breast cancer cases among women previously had been classified as HER2-negative, meaning tumors do not overexpress the HER2 protein.

However, more than half of cases once considered HER2-negative now are classified as HER2-low. This newly defined subtype encompasses breast cancers in which some HER2 proteins are on the cell surface, but not enough to be classified as HER2-positive.

Until the expanded approval of fam-trastuzumab deruxtecan-nxki, patients with HER2-low disease received chemotherapy or endocrine therapy.

The FDA approved fam-trastuzumab deruxtecan-nxki for the new indication based on results of the randomized phase 3 DESTINY-Breast04 trial, which included 557 adults with unresectable or metastatic HER2-low breast cancer.

Researchers randomly assigned 373 patients to fam-trastuzumab deruxtecan-nxki via IV infusion every 3 weeks. The other 184 patients received physician’s choice of chemotherapy.

As Healio previously reported, patients assigned fam-trastuzumab deruxtecan-nxki achieved longer PFS and OS.

“[This] approval highlights the FDA’s commitment to be at the forefront of scientific advances, making targeted cancer treatment options available for more patients,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Having therapies that are specially tailored to each patient’s cancer subtype is a priority to ensure access to safe and innovative treatments.”

The most common adverse events reported among patients treated with fam-trastuzumab deruxtecan-nxki included nausea, fatigue, alopecia, vomiting, constipation, decreased appetite, musculoskeletal pain and diarrhea. The prescribing information includes a boxed warning about risk for interstitial lung disease and embryo-fetal toxicity.




ADD TOPIC TO EMAIL ALERTS

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.



Source link

Advertisement Banner
Previous Post

Consider Patient Preference When Offering CRC Screening Tests

Next Post

How Retraining Your Brain Could Help With Lower Back Pain

Next Post

How Retraining Your Brain Could Help With Lower Back Pain

Discussion about this post

Recommended

Expanding split liver transplants critical to stop children ‘dying on the waitlist’

2 months ago

AbbVie’s Allergan Reaches $2 Billion Opioid Lawsuit Settlement

3 weeks ago

Don't Miss

A Key Food to Grow With Limited Space

August 17, 2022

What is Lab-Grown Meat? | Mark’s Daily Apple

August 17, 2022

Nurse staffing marketplace Incredible Health scores $80M and more digital health fundings

August 17, 2022

New Study Ranks The Healthiest US States; Washington Claims Top Spot

August 17, 2022

© 2022 Pharma News Hubb All rights reserved.

Use of these names, logos, and brands does not imply endorsement unless specified. By using this site, you agree to the Privacy Policy.

Navigate Site

  • News
  • Medicine
  • Health Tech
  • Health Tech
  • Health Living
  • Contact
  • Privacy Policy

Newsletter Sign Up.

No Result
View All Result
  • Home
  • News
  • Medicine
  • Health Tech
  • Health Living
  • Contact
  • Privacy Policy

© 2022 Pharma News Hubb All rights reserved.