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

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.  

New FDA Approval for Pfizer's BESPONSA®

On Thursday, August 17, 2017 Pfizer Inc. 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).1 BESPONSA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs.

BESPONSA is the first and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The full Prescribing Information, including BOXED WARNING, for BESPONSA can be found at http://labeling.pfizer.com/ShowLabeling.aspx?id=9503

New FDA Approval for IMBRUVICA®

On behalf of Pharmacyclics LLC, an AbbVie Company, we wanted to share that today we received US FDA approval for IMBRUVICA® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. With this approval, IMBRUVICA® becomes the first and only therapy specifically approved for adult patients in this disease state. 

   

For your reference, click here to read our company press release and click here to access the complete, updated Prescribing Information. 

 

Important safety highlights include the following:  

 

Warnings and Precautions

  • Hemorrhage: Monitor for bleeding and manage.
  • Infections: Monitor patients for fever and infections, evaluate promptly, and treat. 
  • Cytopenias: Check complete blood counts monthly.
  • Atrial Fibrillation: Monitor for atrial fibrillation and manage.
  • Hypertension: Monitor blood pressure and treat.
  • Second Primary Malignancies: Other malignancies have occurred in patients, including skin cancers, and other carcinomas.
  • Tumor Lysis Syndrome (TLS): Assess baseline risk and take precautions. Monitor and treat for TLS.
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise women of the potential risk to a fetus and to avoid pregnancy while taking the drug and for 1 month after cessation of therapy. Advise men to avoid fathering a child during the same time period.

 

Adverse Reactions

The most common adverse reactions (≥20%) in patients with cGVHD were fatigue, bruising, diarrhea, thrombocytopenia, muscle spasms, stomatitis, nausea, hemorrhage, anemia, and pneumonia.

 

For additional safety information, please see the full Prescribing Information here.

FDA Approves Genentech's RITUXAN HYCELA™

On June 22, 2017, RITUXAN HYCELA™(rituximab/hyaluronidase human) was approved by the US Food and Drug Administration (FDA). 

Genentech Access Solutions offers a full range of access and reimbursement support to help you and your patients understand their coverage and get assistance with out-of-pocket (OOP) costs so treatment can begin as soon as possible. 

Genentech Access Solutions can help your patients and practice address each patient’s coverage scenario: 

  • Full benefits investigations to verify coverage
  • Prior authorization resources
  • Sample billing and coding information
  • Resources for appeals
  • Co-pay assistance option identification to help eligible insured patients with OOP costs
  • Free medicine for qualified uninsured and underinsured patients through the Genentech® Access to Care Foundation 

Click Here for billing and coding information on RITUXAN HYCELA

Click the link below for full Prescribing Information and additional Important Safety Information: https://www.gene.com/download/pdf/rituxan_hycela_prescribing.pdf.

KEYTRUDA Approval for Fixed-dose in Patients with Unresectable or Metastatic Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

Merck is pleased to announce that KEYTRUDA is now approved for 200-mg fixed-dose administration in patients with unresectable or metastatic melanoma.

For more information please click the links below:

Prescribing Information

Medication Guide

Announcement Letter