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

Another New FDA Approval for KEYTRUDA®

On May 25, 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 a first-of-its-kind indication: the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient, solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 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. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established. 

Please click the links below for more information:

Prescribing Information 

Medication Guide

Announcement Letter

Press Release

 

FDA Accelerated Approval of ALUNBRIGTM (brigatinib)

On April 28, 2017 Takeda Oncology announced the FDA approval of ALUNBRIGTM (brigatinib), a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 

Please read the documents below for detailed information on the FDA approval and the prescribing information:

Approval Information

Prescribing Information

Another New FDA Approval for KEYTRUDA®

Merck is pleased to announce that KEYTRUDA is now the only anti–PD-1 approved in combination with carbo/pem for the first-line treatment of patients with nonsquamous metastatic NSCLC (mNSCLC) irrespective of PD-L1 expression. KEYTRUDA is also the only anti–PD-1 approved as first-line monotherapy for patients with nonsquamous and squamous mNSCLC whose tumors have high PD-L1 expression (TPS ≥50%) and are negative for EGFR and ALK genomic tumor aberrations.

Press Release

Announcement Letter