Stay Up
to Date
Stay Up
to Date
Breaking News,
Updates, & More
Breaking News,
Updates, & More
Click Here to
Subscribe
Click Here to
Subscribe

Recap of FDA Drug Approvals in 2019

Web Exclusives - FDA Updates, In the News

According to the FDA’s Center for Drug Evaluation and Research’s (CDER) annual report, Advancing Health Through Innovation: 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. 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.

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.

Related Items
Zepzelca New Therapy Approved for Metastatic Small-Cell Lung Cancer
Web Exclusives published on June 22, 2020 in FDA Updates, Lung Cancer
Opdivo Approved for Advanced Esophageal Squamous-Cell Carcinoma
Web Exclusives published on June 22, 2020 in FDA Updates
FDA News
TON - June 2020, Vol 13, No 3 published on June 16, 2020 in FDA Updates
FDA Approves Cyramza plus Tarceva for First-Line Treatment of Metastatic NSCLC with EGFR Mutation
Web Exclusives published on June 8, 2020 in FDA Updates, Lung Cancer
Opdivo plus Yervoy and Chemotherapy Approved as First-Line Therapy for Metastatic NSCLC, Regardless of PD-L1 Expression
Web Exclusives published on June 2, 2020 in FDA Updates, Lung Cancer
Tecentriq plus Avastin First Immunotherapy Regimen Approved for Metastatic Hepatocellular Carcinoma
Web Exclusives published on June 2, 2020 in FDA Updates, Hepatocellular Carcinoma
Lynparza First Targeted Therapy Approved for Metastatic Prostate Cancer with HRR Mutation
Web Exclusives published on May 26, 2020 in FDA Updates, Prostate Cancer
Tecentriq Approved as First-Line Therapy for Metastatic NSCLC with High PD-L1 Expression
Web Exclusives published on May 26, 2020 in FDA Updates, Lung Cancer
Opdivo-Yervoy First Immunotherapy Combo Approved for First-Line Therapy of Patients with Metastatic NSCLC
Web Exclusives published on May 18, 2020 in FDA Updates, Lung Cancer
Tabrecta First FDA-Approved Targeted Therapy for Metastatic NSCLC and MET Exon 14 Skipping
Web Exclusives published on May 11, 2020 in FDA Updates
Last modified: April 27, 2020