New FDA Approval for Genentech's ALECENSA®

On November 6, 2017, ALECENSA® (alectinib) was approved by the FDA for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)–positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 

The FDA approval letter for ALECENSA can be found at https://www.genentech-access.com/ALECENSA

The full Prescribing Information for ALECENSA can be found at https://www.gene.com/download/pdf/alecensa_prescribing.pdf

New FDA Approval for Genentech's GAZYVA®

On November 16, 2017, GAZYVA® (obinutuzumab), in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma (FL).

The FDA approval letter can be found at https://www.genentech-access.com/gazyva.html

The full Prescribing Information for GAZYVA can be found at https://www.gene.com/download/pdf/gazyva_prescribing.pdf.

FDA Approves Pfizer's BESPONSA™ (inotuzumab ozogamicin)

On August 17, Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). BESPONSA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs.

Links:

Pfizer Press Release

Prescribing Information

FDA Grants Accelerated Approval to Aliqopa

On September 14, 2017 Bayer announced that the U.S. Food and Drug Administration granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.

“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them.”

Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma, a cancer of the lymph system. The lymph system is part of the body’s immune system and is made up of lymph tissue, lymph nodes, the spleen, thymus, tonsils and bone marrow. The National Cancer Institute at the National Insititutes of Health estimates that approximately 72,240 people in the United States will be diagnosed with some form of non-Hodgkin lymphoma this year; approximately 20,140 patients with non-Hodgkin lymphoma will die from the disease in 2017.

Aliqopa is a kinase inhibitor that works by blocking several enzymes that promote cell growth.

Aliqopa received an Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm Aliqopa’s clinical benefit and the sponsor is currently conducting these studies.

Links:

Press Release

Prescribing Information

FDA Approves New Indication for Merck’s KEYTRUDA®

On Sept. 22, 2017 Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.

This indication is approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 

Links:

Press Release

Prescribing Information

Medication Guide

New FDA Approval for Celgene's IDHIFA®

On August 1, 2017, the U.S. Food and Drug Administration approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.

For more information: https://www.idhifa.com

FDA Approves Celgene's IDHIFA®

Celgene Corporation is pleased to announce that IDHIFA is now approved and available for adult patients with relapsed or refractory (R/R) AML and an IDH2 mutation.

Links:

Approval Announcement of IDHIFA

Prescribing Information

New FDA Approval for Pfizer's MYLOTARG™ (gemtuzumab ozogamicin)

On September 1, 2017,  Pfizer announced that the U.S. Food and Drug Administration approved MYLOTARG™ (gemtuzumab ozogamicin) for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.1 MYLOTARG is the first therapy with an indication that includes pediatric AML. It is also the only AML therapy that targets CD33, an antigen expressed on AML cells in up to 90% of patients. approval of MYLOTARG® (gemtuzumab ozogamicin) Injection for IV infusion. The following information is for State Society review:

Click Here to read the press release.

Click Here for prescribing information.