FDA BRIEF: Week of Nov 27, 2017
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.
SUBLOCADE ( 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)
Image credits: Mylan, Indivior