The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2020 > 5 > Notable approvals: FDA okays Tabrecta, adds indication for Farxiga

Notable approvals: FDA okays Tabrecta, adds indication for Farxiga

Posted 08 May 2020 | By Renee Matthews 

Notable approvals: FDA okays Tabrecta, adds indication for Farxiga

The US Food and Drug Administration (FDA) on Wednesday granted accelerated approval to Novartis Pharmaceuticals’ Tabrecta (capmatinib) as the first targeted therapy for adults with metastatic non-small cell lung cancer (NSCLC) who have mutations that drive mesenchymal-epithelial transition (MET) exon 14 skipping. The drug inhibits MET tyrosine kinase, an enzyme associated with cancer cell growth and metastasis.
The agency also approved FoundationOne CDx assay (F1CDx), a companion next-generation sequencing‒based diagnostic for Tabrecta that can detect the mutations leading to MET exon 14 skipping, as well as several other mutations. The diagnostic approval was granted to Foundation Medicine Inc.
“Tabrecta is the first approval specifically for the treatment of patients with non-small cell lung cancer whose tumors have mutations that lead to MET exon 14 skipping. This patient population now has an option for a targeted therapy, which they did not have prior to today,” Richard Pazdur, MD, director of the agency’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in its Center for Drug Evaluation and Research, said in a statement.
Tabrecta also was given Orphan Drug designation, which incentivizes and supports development of therapies for rare diseases. The application had been designated as a Breakthrough Therapy, to allow for its expedited development and review, and given Priority Review status, whereby the agency aimed to act on an application six months of its submission.
New treatment for specific type of heart failure

On Tuesday, the agency approved AstraZeneca’s Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction, a type of heart failure characterized by compromised pumping activity in the left ventricle.
Farxiga, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is the first drug in that class to be approved for lowering the risk of cardiovascular death and hospitalization for heart failure with reduced ejection fraction, the agency noted in a statement. AstraZeneca’s application received Priority Review designation on 6 January 2020.
“This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalization,” Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Farxiga was initially approved In 2014 for improving glycemic control in adults with type 2 diabetes, in concert with diet modification and exercise. FDA then granted Fast Track designation in August 2019 for development of the drug for delaying progression of renal failure and preventing cardiovascular and renal death in patients with chronic kidney disease, with or without type 2 diabetes, AstraZeneca said in a statement.
The following month, the agency handed the drug another Fast Track designation for its development in heart failure, and in October 2019, it approved the drug’s use to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.