FDA Drug Approvals: IMFINZI, ALUNBRIG – Drug and Device Digest

FDA BRIEF: Week of May 8, 2017

FDA approved

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IMFINZI (durvalumab) injection

AstraZeneca. Wilmington, DE, USA

VENTANA PD-L1 (SP263) Assay

Ventana Medical Systems, Inc., Tucson, AZ, USA

INDICATION: Treatment of patients with locally advanced or metastatic urothelial carcinoma who:

  • have disease progression during or following platinum-containing chemotherapy
  • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy.

REG PATHWAY: Accelerated Approval

  • Based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials
  • Also approval for complementary diagnostic for the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma tissue

MECHANISM OF ACTION:  Human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of PD-L1 with PD-1 and CD80;  releases the inhibition of immune responses, without inducing antibody dependent cell-mediated cytotoxicity


  • Multicenter, multicohort, open-label clinical trial, n=182 patients with locally advanced or metastatic urothelial carcinoma; had progressed while on or after a platinum-based therapy
  • Major efficacy outcome measures: Confirmed Objective Response Rate (ORR) according to RECIST v1.1 by Blinded Independent Central Review (BICR), and duration of response (DoR)
  • Responding patients: 31; 45% had ongoing responses of 6 months or longer, 16% had ongoing responses of 12 months or longer
  • Confirmed ORR: 26.3%  in 95 patients with a high PD-L1 score, 4.1% in 73 patients with a low or negative PD-L1 score


  • Most common adverse reactions: Fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral edema, and urinary tract infection
  • Infection and immune-related adverse events: Pneumonitis, hepatitis, colitis, thyroid disease, adrenal insufficiency, diabetes



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ALUNBRIG (brigatinib) tablets

Ariad Pharmaceuticals, Inc. (Takeda), Cambridge, MA, USA

INDICATION:  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

REG PATHWAY: BLA. Accelerated Approval, Breakthrough Therapy Designation, Orphan Drug Designation, Priority Review

  • Accelerated approval based on tumor response rate and duration of response
  • Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial

MECHANISM OF ACTION:  Tyrosine kinase inhibitor with in vitro activity against multiple kinases,  inhibited the in vitro proliferation of cell lines expressing EML4-ALK and NPM-ALK fusion proteins, dose-dependent inhibition of EML4-ALK-positive NSCLC xenograft growth in mice


  • Two-arm, open-label, multicenter trial, n=222, patients with locally advanced or metastatic ALK-positive NSCLC who had progressed on crizotinib, had documented ALK rearrangement based on an FDA-approved test  or a different test with adequate archival tissue to confirm ALK arrangement by the Vysis® ALK Break-Apart fluorescence in situ hybridization Probe Kit test. BRIGATINIB 90 mg or 180 mg
  • Major efficacy outcome measure: Confirmed overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) evaluated by an Independent Review Committee (IRC); Additional measures included Investigator-assessed ORR, duration of response (DOR), intracranial ORR, and intracranial DOR
  • ORR: 48% (90 mg), 53% (180 mg) with DOR of 13.8 months in both arms
  •  Intracranial ORR: 42% (90 mg), 67% (180 mg), DOR of at least 4 mo.


  • Most common adverse reactions: Nausea, diarrhea, fatigue, cough, headache
  • Most common serious adverse reactions: Pneumonia and ILD/pneumonitis
  • Fatal adverse reactions: Pneumonia, sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis, urosepsis


Image Source: Google

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