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

Two New Indications for Merck's KEYTRUDA®

On May 18, 2017 Merck announced that the U.S. Food and Drug Administration (FDA) has approved two new indications for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. In the first-line setting, KEYTRUDA is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. 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 the confirmatory trials. In the second-line setting, KEYTRUDA is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA is approved for use in these indications at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

For more information please click on the links below:

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