FDA Approves NERLYNX® for Adjuvant Treatment of HER2 Positive Breast Cancer

September 25th, 2017

The FDA on July 17, 2017 approved NERLYNX® (Neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant Trastuzumab (HERCEPTIN®)-based therapy. NERLYNX® is a potent, irreversible, oral Tyrosine Kinase Inhibitor, of HER1, HER2 and HER4 (pan-HER inhibitor). NERLYNX® is the first TKI approved by the FDA, shown to reduce the risk for disease recurrence, in patients with early stage HER2-positive breast cancer and demonstrated significantly improved 2-year invasive Disease Free Survival.


FDA Approves First Biosimilar for Cancer Treatment

September 20th, 2017

The FDA on Sept. 14, 2017 approved MYASI® (Bevacizumab-awwb) as a Biosimilar to AVASTIN® (Bevacizumab). MYASI® is the first Biosimilar approved in the U.S. for the treatment of cancer. A Biosimilar must show that it has no clinically meaningful differences in terms of safety and effectiveness from the already approved biological product (also known as reference product). A Biosimilar product can only be approved by the FDA if it has the same mechanism of action, route of administration, dosage form and strength as the reference product, and only for the indications and conditions of use, that have been approved for the reference product. The approval of MYASI® was based on comparisons of extensive structural and functional product characterization, animal data, human PharmacoKinetic and pharmacodynamic data, clinical immunogenicity, between MYASI® and AVASTIN® (Bevacizumab), and it was noted that MYASI® is highly similar to AVASTIN® and that there are no clinically meaningful differences between the two products.


Screening Mammography Starting at Age 40 years May Reduce Breast Cancer Deaths by 40 percent

September 12th, 2017

In the US, about 33 million screening mammograms are performed each year. Currently, the major national health care organizations in the US have different recommendations for screening mammography which has led to some confusion and emotional counterarguments. These several different recommendations include 1) Annual screening at ages 40 to 84 years. 2) Annual screening at ages 45 to 54 years and then biennially at ages 55 to 79 years. 3) Biennial screening at ages 50 to 74 years.

In a recently published study (CANCER,  August 21, 2017), it was noted  that the greatest breast cancer-specific mortality reduction was achieved with annual screening of women starting at age 40 years, saving 29,369 lives from breast cancer. This is the first study to compare the three most widely discussed recommendations for screening mammography, head to head.


First CAR T-Cell Immunotherapy Approved by the FDA for Acute Lymphoblastic Leukemia

September 11th, 2017

The FDA on August 30, 2017, granted regular approval to KYMRIAH® (Tisagenlecleucel) for the treatment of patients up to age 25 years with B-cell precursor Acute Lymphoblastic Leukemia (ALL), that is refractory or in second or later relapse. KYMRIAH® is the first Chimeric Antigen Receptor (CAR) T-cell immunotherapy approved by the FDA. A single infusion of KYMRIAH® was highly efficacious, in patients with relapsed and refractory ALL, and was associated with a high and durable Remission Rate. This technology may be applied to other malignancies, as new antigen targets are identified.