FDA BRIEF: Week of August 8, 2016

FDA approved

KEYTRUDA (pembrolizumab) injection

Merck Sharp & Dohme Corp. Whitehouse Station, NJ, USA

SUPPLEMENTARY INDICATION:  Treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy


REG PATHWAY: Supplementary BLA, Accelerated Approval, Priority Review


  • Single multicenter, nonrandomized, open-label, multicohort study(n=174, HNSCC)
  • KEYTRUDA, 10 mg/kg every 2 weeks or 200 mg every 3 weeks,  until unacceptable toxicity or disease progression
  • Major efficacy outcome measures: Objective Response Rate ( ORR), RECIST 1.1 and Duration of Response
  • ORR : 16% (95% CI: 11, 22) with a complete response rate of 5%
  • Median Duration of Response had not been reached (range 2.4+ to 27.7+ months)
  • Continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials


  • Most common adverse reactions: Fatigue, decreased appetite, and dyspnea
  • Similar to previously approved indications of melanoma or NSCLC
  • Increased incidence of facial edema (10% all grades, 2.1% grades 3-4), new or worsening hypothyroidism (14.6% all grades).


SUSTOL (granisetron) extended-release injection

Heron Therapeutics, Redwood City, CA, USA

INDICATION: ndicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

REG PATHWAY: NDA, 505 (b)(2). Initial applications rejected in 2010, 2013.

MECHANISM OF ACTION: Selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist Blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin.


  • Randomized, multicenter, double-blind, parallel group study (n=733), SUSTOL vs. palonosetron hydrochloride, cancer patients with MEC or AC
  • Primary Endpoint:  Complete Response defined as no emetic episodes and no use of rescue medications.
  • Non-inferiority of SUSTOL to palonosetron hydrochloride in acute and delayed phases of MEC and of AC combination chemotherapy

SAFETY: Injection Site reactions, gastrointestinal disorders, hypersensitivity reactions, serotonin symdrome






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