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Following Positive Results of Phase III TULIP Trial: FDA Accepts Byondis’...

The U.S. Food & Drug Administration (FDA) has accepted Byondis' submission of a Biologics License Application (BLA) for trastuzumab duocarmazine (previously known as...

HER2, Trastuzumab and the Development of Novel Antibody-drug Conjugates

In the mid-1970s, scientists discovered that certain genes, when mutated, can cause cancer.  Based on this observation they theorized that by targeting these oncogenes,...
ESMO 2017 - 3

Trastuzumab Deruxtecan Receives Breakthrough Therapy Designation for HER2+ Metastatic Breast Cancer...

The U.S. Food and Drug Administration (FDA) has granted trastuzumab deruxtecan* (Enhertu®; Daiichi Sankyo and AstraZeneca), a HER2 directed antibody-drug conjugate (ADC), Breakthrough Therapy...

U.S. Patent for Bolt Biotherapeutics’ Boltbody™ ISAC Platform Technology is a...

San Francisco Bay Area-based Bolt Biotherapeutics confirmed that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,675,358 entitled "Antibody Adjuvant...

HER2-targeting Trastuzumab Deruxtecan Shows Promise in Patients with Non-breast/Gastric Cancers

Results from a phase I study investigating fam-trastuzumab deruxtecan-nxki (formerly known as DS-8201a; Enhertu®; Daiichi Sankyo and AstraZeneca) showed signs of clinical activity of...

Ado-trastuzumab emtansine (Kadcyla®)

International Nonproprietary Names (INN) Ado-trastuzumab emtansine Prescription Drug Yes Class Antineoplastic Agents US Brand Name Kadcyla® Other names ado-trastuzumab emtansine, trastuzumab-DM1, T-DM1 Available as a generic drug No Marketing Authorization Genentech/Roche United States Adopted Name (USAN) Trastuzumab...
Speakers and attendees during the morning sessions on Wednesday December 11, 2019. during the San Antonio Breast Cancer Symposium being held at the Henry B. Gonzalez Convention Center in San Antonio, TX. This year is the 42nd Anniversary of the meeting where over 7,500 physicians, researchers, patient advocates and healthcare professionals from over 90 countries attended the meeting which features the latest research on breast cancer treatment and prevention. Photo Courtesy 2019 © MedMeetingImages/Todd Buchanan

SABCS 2019: DESTINY-Breast01 Trial of Trastuzumab Deruxtecan Shows Positive Results in...

Detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial (NCT03248492) of trastuzumab deruxtecan (DS-8201; fam-trastuzumab deruxtecan in the US only) were presented...
Featured Image: Ado-trastuzumab emtansine (Kadcyla; Genentech/Roche), known as T-DM1 during. Courtesy: Genentech/Roche.

Pharmacokinetic Considerations to Maximize an ADC’s Therapeutic Index

The Antibody-drug Conjugate (ADC) field is poised for several significant advances in solid tumors as the industry has built upon knowledge gained over the...

Highlights in Development: September 2019

In September 2019, a number of articles discussing antibody-drug conjugates were published in a variety of journals.  Here is an overview of some of...

Ado-trastuzumab emtansine Approved for the Treatment of Early Breast Cancer

In early May 2019, the United States Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla®, Genentech/Roche; T-DM1) for the adjuvant treatment of patients...

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