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A Look Back at FDA News in the Month of December

Published Online:5:08 PM, Wed January 3, 2018
The FDA closed out the year by approving several new agents last month, including bevacizumab for glioblastoma, cabozantinib for renal cell carcinoma, nivolumab for melanoma, bosutinib for chronic myeloid leukemia, and pertuzumab for HER2+ breast cancer. In addition, several agents were granted a priority review designation. Here is a look back at all the FDA activity that took place in December:

Bevacizumab Granted Full FDA Approval for Glioblastoma

After previously receiving an accelerated approval, bevacizumab (Avastin) was granted a full approval by the FDA on December 4 for the treatment of adult patients with glioblastoma that progressed following prior therapy, according to Genentech, the manufacturer of the VEGF inhibitor.


FDA Removes Holds on 2 Nivolumab-Based Multiple Myeloma Clinical Trials

On December 5, the FDA lifted the partial clinical holds placed on the phase I CheckMate-039 and phase II CA204142 trials in October. Both trials were exploring nivolumab-based regimens in patients with relapsed/refractory multiple myeloma.

Maintenance Rucaparib Granted Priority Review for Ovarian Cancer

Based on results from the phase III ARIEL3 trial, in which maintenance rucaparib improved median progression-free survival (PFS) by 11.2 months versus placebo for patients with BRCA-mutant platinum-sensitive ovarian cancer, the FDA granted the PARP inhibitor a priority review on December 5 for use as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Pembrolizumab Receives FDA's Priority Review in PMBCL

On December 10, pembrolizumab (Keytruda) received a priority review designation by the FDA for the treatment of adult and pediatric patients with relapsed/refractory primary mediastinal large B-cell lymphoma (PMBCL), according to a press release from Merck, the manufacturer of pembrolizumab. 

Nivolumab/Ipilimumab Combo Granted FDA's Priority Review for RCC

Based on findings of the phase III CheckMate-214 trial, a supplemental biologics license application (sBLA) for the combination of nivolumab and ipilimumab was granted a priority review by the FDA on December 13 as a frontline treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC).

Frontline Osimertinib Granted FDA's Priority Review for NSCLC

On December 17, a supplemental new drug application (sNDA) for osimertinib (Tagrisso) was granted a priority review by the FDA as a first-line treatment for patients with non–small cell lung cancer (NSCLC) whose tumors harbor EGFR mutations (exon 19 deletions or exon 21 [L858R] substitution mutations).


Frontline Cabozantinib Granted FDA Approval for Advanced RCC

Based on results of the phase II CABOSUN trial, cabozantinib (Cabometyx) was approved by the FDA on December 18 for previously untreated patients with advanced renal cell carcinoma (RCC).

Bosutinib Receives FDA Approval for Newly-Diagnosed Ph+ CML

Also on December 18, bosutinib (Bosulif) was approved by the FDA as a first-line treatment for patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

Adjuvant Nivolumab Granted FDA Approval for Melanoma 

Nivolumab (Opdivo) received FDA approval for the adjuvant treatment of patients with completely resected melanoma with lymph node involvement or metastatic disease on December 19.

Adjuvant Pertuzumab Regimen Receives FDA Approval for HER2+ Breast Cancer

Based on findings from the APHINITY trial, pertuzumab (Perjeta) was approved by the FDA in combination with trastuzumab (Herceptin) and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk for recurrence on December 19.

Apalutamide Granted FDA's Priority Review for Nonmetastatic CRPC

Based on data from the phase III SPARTAN trial (ARN-509-003), apalutamide (ARN-509) was granted a priority review by the FDA on December 20 for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.

Frontline Avelumab/Axitinib Combo Receives FDA's Breakthrough Designation for RCC

The PD-L1 inhibitor avelumab (Bavencio) was granted a breakthrough therapy designation by the FDA on December 20 for use in combination with the VEGF inhibitor axitinib (Inlyta) in treatment-naïve patients with advanced renal cell carcinoma (RCC).

Adjuvant Dabrafenib/Trametinib Granted Priority Review by FDA for BRAF+ Melanoma

Based on findings of the phase III COMBI-AD study, a supplemental new drug application (sNDA) for dabrafenib (Tafinlar) combined with trametinib (Mekinist) was granted a priority review by the FDA as an adjuvant treatment for patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection on December 21.

Stereotactic Radiotherapy Device Given Green Light for Early Breast Cancer by FDA

Based on findings from a 17-patient study, a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod was approved by the FDA as a treatment for patients with early breast cancer on December 21.

Nilotinib Label for CML Updated by FDA With Discontinuation Provision

On December 22, the label for nilotinib (Tasigna) was updated by the FDA with a provision stating patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor could be eligible to stop treatment after having recieved for at least 3 years and having achieved the specific predetermined criteria.

Ivosidenib Submitted for FDA Approval in IDH1+ AML

Based on results of a phase I trial presented at the 2017 ASH Annual Meeting, a new drug applicaton (NDA) for ivosidenib (AG-120) was submitted for FDA approval on December 25 for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia (AML), according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.

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