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

Webinar:First-line Treatment Options for Metastatic Non–Small Cell Lung Cancer (NSCLC)

Merck is sponsoring an interactive live webcast entitled: First-line Treatment Options for Metastatic Non–Small Cell Lung Cancer (NSCLC) 

Learning Objectives 

  •  Understand the clinical data associated with the first-line treatment options for metastatic NSCLC 
  •  Identify the appropriate patient with metastatic NSCLC eligible for first-line treatment option 

Click Here to read the Webcast invitation and for directions on registering for the event. 

New FDA Approval for KEYTRUDA®

On March 14, 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 adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. Under the FDA’s accelerated approval regulations, this indication is approved 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. 

Click Here to read the entire Press Release. 

Additional Information:


Announcement Letter

Approval Letter

Prescribing Information

Medication Guide

SUSTOL® Receives NCCN Category 1 Recommendation

On February 24, 2017, Heron Therapeutics, Inc. announced the inclusion of SUSTOL® (granisetron) extended-release injection as part of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis Version 1.2017. 

The NCCN has given SUSTOL a Category 1 recommendation, the highest level category of evidence and consensus, for use in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving HEC or MEC regimens. Importantly, the guidelines identify SUSTOL as a “preferred” agent for preventing CINV following MEC. Further, the guidelines highlight the unique, extended-release formulation of SUSTOL. 

Click Here to read the entire Press Release

Click Here to read the NCCN Guidelines

Oncotype DX Press Release re: AJCC Cancer Staging Manual

REDWOOD CITY, Calif., Dec. 22, 2016 /PRNewswire/ -- Genomic Health, Inc. (NASDAQ: GHDX) today announced that based on unparalleled clinical evidence, the American Joint Committee on Cancer (AJCC) incorporated the Oncotype DX® test in its recently published Eighth Edition AJCC Cancer Staging Manual. Representing a rigorous, multi-disciplinary assessment, the updated criteria identify Oncotype DX as the only multi-gene test with Level I evidence to determine formal staging of breast cancer patients, based on clinical evidence in more than 63,000 patients.

"For the first time, AJCC has added molecular signatures to complement the traditional anatomic features of the disease, transitioning cancer diagnosis and care to truly personalized medicine," said Steven Shak, M.D., chief scientific officer, Genomic Health. "We believe this groundbreaking milestone will enhance physicians' ability to deliver the excellent patient outcomes demonstrated across multiple prospective studies of the Oncotype DX test."

Effective January 2018, the new AJCC Prognostic Stage Groups will add the Oncotype DX Breast Recurrence Score™, hormonal status (ER, PR), and HER2 status to nodal status, tumor size, and tumor grade for staging breast cancer. For patients with node-negative disease or micrometastases in the nodes, a low Oncotype DX Recurrence Score (RS<11) classifies a patient as having the most favorable Prognostic Stage, regardless of tumor grade or tumor size (up to five centimeters).

As part of the implementation process, all AJCC partners, including the College of American Pathologists (CAP) and the National Comprehensive Cancer Network (NCCN), will develop and update protocols and tools to facilitate successful adoption of the required new staging system rules in 2018. The electronic version of the Eighth Edition AJCC Cancer Staging Manual is scheduled to be available the first quarter of 2017.

As stated in the AJCC publication1, "Based on the best available evidence at this time, the Expert Panel determined that it was appropriate to incorporate multigene molecular profiling to incorporate the Oncotype DX score into staging for the subgroup of patients defined by Arm A of the TAILORx study. These patients should be staged according to the AJCC Prognostic Stage Groups. The findings for the ODX (Oncotype DX) test are supported by Level I Evidence (large-scale prospective clinical trial data)."

The results of the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) were published in The New England Journal of Medicine in 2015. Additionally, the Eighth Edition AJCC Cancer Staging Manual cites clinical outcomes data from tens of thousands of patients in the United States generated by the Surveillance, Epidemiology, and End Results (SEER) Registry program of the National Cancer Institute (NCI), demonstrating that patients with low Recurrence Scores have excellent breast cancer survival at five years.