A roundup of approvals of new molecular entities (NMEs) from the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), featuring NME approvals from Roche, AbbVie, Celgene, and Nabriva Therapeutics.

Roche Receives FDA Approval for Rare Cancer Drug Rozlytrek

The FDA has approved Roche’s Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotropic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments.

This is the third time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. The agency says the approval marks a new paradigm in the development of cancer drugs that are “tissue agnostic.”

The previous tissue agnostic indications approved by the FDA were Merck & Co’s Keytruda pembrolizumab for tumors with microsatellite instability-high (MSI-H) or mismatch-repair-deficient tumors in 2017 and Loxo Oncology’s Vitrakvi (larotrectinib) for NTRK gene fusion tumors in 2018. Loxo Oncology was acquired by Eli Lilly and Company earlier this year (February 2019).

Rozyltrek has been approved by Japan’s Ministry of Health, Labour and Welfare as well as by the European Medicines Agency.

Source: FDA, Roche

AbbVie Receives FDA Approval for Rheumatoid Arthritis Drug Rinvoq

The FDA has approved AbbVie’s Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active rheumatoid arthritis.

Rinvoq is an oral, small-molecule JAK inhibitor being studied for moderately to severely active rheumatoid arthritis and other immune-mediated diseases.

Rinvoq is under review by the European Medicines Agency as well as regulatory authorities in Canada and Japan.

Source: AbbVie

Celgene Receives FDA Approval for Bone Marrow Disorder Drug Inrebic

The FDA has approved Celgene’s Inrebic (fedratinib) to treat adult patients with certain types of myelofibrosis, a chronic disorder where scar tissue forms in the bone marrow.

The FDA granted the approval of Inrebic to Impact Biomedicines, a wholly owned subsidiary of Celgene.

Source: FDA, Celgene

Nabriva Therapeutics Receives FDA Approval for Pneumonia Drug Xenleta

The FDA has approved Nabriva Therapeutics’ Xenleta (lefamulin), a semi-synthetic pleuromutilin antibiotic, for treating adults with community-acquired bacterial pneumonia (CABP) through oral and intravenous formulations. Community-acquired pneumonia occurs when someone develops pneumonia in the community rather than a hospital.

Xenleta received FDA’s Qualified Infectious Disease Product (QIDP) designation. The QIDP designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of QIDP designation, Xenleta was granted priority review under which the FDA’s goal is to take action on an application within an expedited time frame.

Source: FDA, Nabriva Therapeutics