New FDA Approval for CINVANTI™

On Nov. 9, 2017, Heron Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved CINVANTI™(aprepitant) injectable emulsion, for intravenous infusion. CINVANTI is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). With this approval, Heron now is the only company with approved injectable therapies that address the two primary mechanisms of CINV: SUSTOL®, a serotonin-3 (5-HT3) receptor antagonist, and CINVANTI, an NK1 receptor antagonist.

Click Here for full prescribing information: www.CINVANTI.com

New FDA Approval for Sprycel ®

On November 10, 2017 announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel ® (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).1 This approval for Sprycel in pediatric patients with Ph+ CML in chronic phase was granted under priority review, and the indication received orphan drug designation from the FDA.

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

New FDA Approval for Pfizer's SUTENT®

Pfizer Oncology is proud to announce that SUTENT® (sunitinib malate) has been approved for adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy. SUTENT is the first approved treatment for patients with RCC in this setting.

For patients requiring financial assistance, Pfizer Oncology has support programs that may be able to help. You can learn more at the product website SUTENT.com.

Visit SUTENT.com to:

- Read updated full Prescribing Information

- Find out about access and coverage support for your patients

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 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