FDA BRIEF: Week of Nov 27, 2017

FDA approved


OGIVRI (trastuzumab-dkst) injection

Mylan

INDICATION:

  • Adjuvant Breast Cancer: Adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature
  • Metastatic Breast Cancer: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, single-agent treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
  • Metastatic Gastric Cancer: In combination with cisplatin and capecitabine or 5-fluorouracil, for HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

ADDRESSING UNMET NEED:  First biosimilar to Herceptin (trastuzumab, Genentech, Inc.)

REGULATORY PATHWAY: BLA

  • Approved as biosimilar, not as an interchangeable product
  • Approval was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, and clinical studies including clinical immunogenicity between Ogivri and U.S.-licensed Herceptin
  • Data demonstrate Ogivri is highly similar to U.S.-licensed Herceptin
  • No clinically meaningful differences between the products.

LABEL


CaptureSUBLOCADE ( buprenorphine ) monthly subcutaneous injection

 

 Indivior Inc.

INDICATION: Treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal buprenorphine‐containing product, followed by dose adjustment for a minimum of 7 days.
Should be used as part of a complete treatment plan that includes counseling and psychosocial support

ADDRESSING UNMET NEED:

  • Given scale of the opioid crisis, FDA expanding access to treatments that can help people pursue lives of sobriety
  • New treatment option for patients in recovery; benefit of once-monthly injection vs. other forms of buprenorphine
  • Reducing burden of taking medication daily as prescribed
  • Medication-assisted treatment (MAT); part of comprehensive recovery plan opioid use disorder

REGULATORY PATHWAY: NDA

  • Buprenorphine currently approved to administer as a tablet, film or implant
  • Independent FDA advisory committee supported the approval
  •  Priority Review and Fast Track designations
  • Schedule III

MECHANISM OF ACTION & DESCRIPTION:  Partial agonist at the mu‐ opioid receptor and an antagonist at the kappa‐opioid receptor

  • Drug-device combination product that utilizes buprenorphine and the Atrigel Delivery System in a pre-filled syringe

EFFICACY:  

  • A double‐blind efficacy and safety study and an opioid blockade study , n=848, subjects with moderate-to-severe OUD who began treatment with buprenorphine/naloxone sublingual film followed by  Sublocade by injection vs. placebo
  • MAT Response: Urine drug screening and self-reporting of illicit opioid use during six-month treatment period
  • More weeks without positive urine tests or self-reports of opioid use vs. placebo
  • Higher proportion of patients with no evidence of illicit opioid use throughout the treatment period vs. placebo

SAFETY:

  • Boxed warning : Risks of intravenous self-administration; solid mass could cause occlusion, tissue damage or embolus
  • Prescribed and dispensed as part of a Risk Evaluation and Mitigation Strategy (REMS)

LABEL


Image credits: Mylan, Indivior

 

 

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