Recap of FDA Drug Approvals in 2019

FDA Approvals, News & Updates, Web Exclusives

According to the FDA’s “Center for Drug Evaluation and Research (CDER) Annual Report: New Drug Therapy Approvals 2019,” the agency approved 48 novel drugs in 2019. Although this number does not approach the record of 59 approvals in 2018, it far surpasses the mere 22 approvals that occurred in 2016.

In 2019, oncology drugs received the most FDA approvals—11 in total. Seven of these approvals were for drugs used in the treatment of solid tumors and 4 were for drugs used to treat hematologic malignancies. These approvals included innovative drugs never before used in clinical practice as well as biosimilars of previously approved reference drugs already on the market. There were also several approvals for drugs used to treat rare or “orphan” cancers.

Some of the drugs approved for the treatment of hematologic cancers were selinexor (Xpovio; Karyopharm Therapeutics), a nuclear export inhibitor, which was approved in combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received ≥4 previous therapies; and zanubrutinib (Brukinsa; BeiGene), a Bruton’s tyrosine kinase inhibitor, which was granted accelerated approval for the treatment of patients with mantle-cell lymphoma who have received ≥1 previous therapies.

For patients with solid tumors, drug approvals included darolutamide (Nubeqa; Bayer), an oral androgen receptor inhibitor, which is indicated for the treatment of nonmetastatic and castration-resistant prostate cancer; erdafitinib (Balversa; Janssen), the first targeted treatment for urothelial carcinoma, and the first FGFR kinase inhibitor to be approved by the FDA; and entrectinib (Rozlytrek; Genentech), an oral kinase inhibitor, which was approved for the treatment of adults and adolescents whose cancer involves NTRK gene fusion that has no effective treatments, as well as for the treatment of adults with metastatic non–small-cell lung cancer and a ROS1 mutation.

For patients with rare and difficult-to-treat cancers, drug approvals included fedratinib (Inrebic; Celgene), an oral kinase inhibitor, for adults with intermediate-2 or high-risk primary or secondary myelofibrosis; and pexidartinib (Turalio; Daiichi-Sankyo), a kinase inhibitor, for adults with symptomatic tenosynovial giant-cell tumor.

Approvals for biosimilars included luspatercept-aamt (Reblozyl; Celgene) for the treatment of anemia in patients with beta thalassemia who require red blood cell transfusions; fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi-Sankyo) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received ≥2 previous treatment regimens; enfortumab vedotin-ejfv (Padcev; Astellas Pharma/Seattle Genetics), for the treatment of locally advanced or metastatic urothelial cancer; and polatuzumab vedotin-piiq (Polivy; Genentech) in combination with other agents to treat adults with relapsed or refractory diffuse large B-cell lymphoma who have received ≥2 previous therapies.

In a statement released in January 2019, the FDA had said that it expected an increase in the number of approvals for cell and gene therapies in the near future, and that it anticipated receiving more than 200 investigational new drug applications during 2020. The agency asserted that its commitment to an accelerated approval pathway, which allows faster review for potentially life-saving gene therapy products that have significant therapeutic advantages, would also increase the number of approvals.

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