A Record Number of FDA Drug Approvals in 2018 Is Followed by an Encouraging Start for 2019

Following a record number of approvals in 2018, the FDA has recently approved two new drugs with many more anticipated approvals later in the year.

Trazimera to Treat Human Epidermal Growth Factor Receptor-2 (HER2) Overexpressing Metastatic Breast Cancer

An article in Biospace reported the results from a study comparing Pfizer’s Trazimera with Herceptin led to the FDA’s approval of Trazimera, a monoclonal antibody biosimilar. The comparative study, REFLECTIONS B327-02, was included in the analysis as noted in the British Journal of Cancer. Trazimera met FDA requirements for safety, efficacy, and potency in HER2 overexpressing metastatic breast cancer (cancer that has spread to other parts of the body).

Human epidermal growth factor receptor 2 (HER2) is a monoclonal antibody (protein) found on the surface of some cancer cells that can cause these cells to divide and grow. Signals sent out by the HER2 gene results in HER2 overexpression.

Trazimera targets and locks onto the HER2 protein. As a result, the drug is able to block receptors, thus putting a stop to cell division and growth.

Trazimera to Treat HER2 Overexpressing Metastatic Gastric Adenocarcinoma of the Esophagus and the Gastro-esophageal Junction

Trazimera was simultaneously approved for HER2 overexpressing metastatic gastric adenocarcinoma of the esophagus and the gastro-esophageal junction, one of the leading causes of cancer mortality in the world.  It is considered one of the fasted rising malignancies with extremely poor prognosis. The majority of gastric cancers are diagnosed at an advanced stage.

Where Does The Disease Originate?

Gastroesophageal (GE) junction is the lower part of the esophagus connecting to the stomach where the esophageal sphincter is located. The sphincter is a muscle that controls the movement of food. The GE junction is situated below the diaphragm, beneath the lungs.

Adenocarcinomas are cancers that begin in glandular cells. As the name implies, a gastroesophageal junction adenocarcinoma is a cancer that begins in glandular cells located near the GE junction.

About Treatment

Although carcinomas that overexpress HER2 are generally resistant to conventional chemotherapy, they have recently shown a response to targeted therapy, as in the case of Trazimera.

Treatment for gastroesophageal junction adenocarcinomas is similar to that of cancers of the esophagus as it is considered to be a form of esophageal cancer. When comparing this disease to breast cancer, there are indications that HER2 gastric cancer may have other probable causes or outcome apart from those of breast cancer.

A number of studies have shown that the amplification of the HER2/neu gene and overexpression of the HER2 protein occur in gastric and gastroesophageal junction adenocarcinoma.

FDA Approval and New Drug Applications

Sanofi/Regeneron’s Dupixent received approval for moderate-to-severe dermatitis for patients ages twelve to seventeen.

Eli Lilly’s Cyramaza Met its Primary Endpoint for Metastatic Non-Small Cell Lung Cancer with EGFR Mutations

The next step for Cyramaza will be an application for regulatory approval worldwide based on patient’s improved disease-free response in its Phase 3 trial.

Akebia Therapeutics’ Vadadustat Meets Its Primary Endpoint for Anemia Resulting From Chronic Kidney Disease (CKD)

Akebia’s Japanese partner, Mitsubishi Tanabe Pharma Corporation, conducted two successful Phase 3 trials of Vadadustat that open the door to a Japanese New Drug Application for 2019.


Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

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