This article is more than 5 years old. Information may no longer be current.

FDA grants priority review to multiple hematology/oncology agents

Issue: February 25, 2018

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA has granted priority review to nine drug applications for the treatment of hematologic malignances and solid tumors.

These include:

• apalutamide (ARN-509, Janssen) — an oral androgen receptor inhibitor that inhibits the action of testosterone in prostate cancer cells and prevents androgen from binding to the androgen receptor — for the treatment of men with nonmetastatic castration-resistant prostate cancer;
• brentuximab vedotin (Adcetris, Seattle Genetics) — an antibody-drug conjugate directed to CD30, a defining marker of classical Hodgkin lymphoma — for use with chemotherapy as initial treatment of advanced classical Hodgkin lymphoma;
• dabrafenib (Tafinlar, Novartis) — a BRAF inhibitor — plus trametinib (Mekinist, Novartis), a MEK 1/2 inhibitor, for the adjuvant treatment of patients with stage III melanoma who harbor BRAF V600E or V600K mutations;
• daratumumab (Darzalex; Janssen, Genmab) — a monoclonal antibody — in combination with bortezomib (Velcade, Millennium/Takeda), melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant;
• iobenguane I 131 (Azedra, Progenics Pharmaceuticals) — a substrate for norepinephrine reuptake transporter, which is highly expressed in neuroendocrine tumors — for the treatment of patients with malignant, recurrent or unresectable pheochromocytoma and paraganglioma;
• nivolumab (Opdivo, Bristol-Myers Squibb) — a PD-1 checkpoint inhibitor — plus ipilimumab (Yervoy, Bristol-Myers Squibb), an anti-CTLA-4 antibody, for the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma;
• osimertinib (Tagrisso, AstraZeneca) — a third-generation epidermal growth factor receptor tyrosine kinase inhibitor — for the first-line treatment of EGFR-positive metastatic non-small cell lung cancer;
• pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — for treatment of patients with relapsed or refractory primary mediastinal large B-cell lymphoma; and
• tisagenlecleucel (Kymriah, Novartis) — the first FDA-approved chimeric antigen receptor T-cell therapy — for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for or relapse after autologous stem cell transplant.

For more information on these FDA actions and others, visit Healio.com/HemOnc and search “FDA news.”