FDA Drug Approvals: MVASI, SOLOSEC, ALIQOPA – Drug and Device Digest

Weeks of September 11 and 18, 2017


MVASI (bevacizumab-awwb) solution for intravenous infusion 

Amgen, Inc


  • Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
  • Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.
  • Metastatic renal cell carcinoma, in combination with interferon alfa.
  • Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

ADDRESSING UNMET NEED: First biosimilar (to Avastin)  approved in the U.S. for the treatment of cancer

REG PATHWAY: BLA (biosimilar, not an interchangeable product)

  • Postmarketing commitments: Drug substance stability, method validation, endotoxin detection method

DESCRIPTION:  Recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in in vitro and in vivo assay systems

BIOSIMILARITY: Extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and clinical safety and effectiveness data


  • 4 Studies in Metastatic Colorectal Cancer: Double blind, open label, survival improvement
  • Adjuvant Treatment of Colon Cancer: No efficacy
  • Unresectable Non–Squamous Non–Small Cell Lung Cancer:  Single, large, randomized, active-controlled, open-label, multicenter study. Higher Overall Survival
  • Glioblastoma: Open-label, multicenter, randomized, non-comparative study.Efficacy based on WHO radiographic criteria and by stable or decreasing corticosteroid use
  • Metastatic Renal Cell Carcinoma:  Multicenter, randomized, double-blind,
    international study.  Statistically significantly prolonged progression free survival
  • Persistent, Recurrent, or Metastatic Carcinoma of the Cervix: Randomized, four-arm, multi-center trial. Higher overall survival


  • Boxed Warning: Increased risk of gastrointestinal perforations; surgery and wound healing complications; severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal bleeding
  • Serious expected side effects:  Perforation or fistula, arterial and venous thromboembolic events), hypertension, encephalopathy syndrome, proteinuria, ovarian failure
  • Common expected side effects: Epistaxis), headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis


Image result for solosec logo

SOLOSEC (secnidazole) oral granules

Symbiomix Therapeutics

INDICATION: Treatment of bacterial vaginosis in adult women


  • New medication for bacterial vaginosis
  • First one-dose oral regimen for most common vaginal infection in adult women


  • Qualified Infectious Disease Product (QIDP) designation
  • Fast Track designation, Priority Review
  • Deferred pediatric assessments

MECHANISM OF ACTION:  Nitroimidazole antimicrobial drug


  • Two randomized placebo-controlled clinical trials, n=144 and 189, patients with diagnosed bacterial vaginosis
  • Efficacy: Clinical outcome in 21 to 30 days, “normal” vaginal discharge, negative
    “whiff” test, and clue cells <20%
  • Statistically significantly greater % clinical outcome with Solosec


  • Most common adverse reactions: Vulvo-vaginal candidiasis, headache, nausea, diarrhea, abdominal pain, vulvovaginal pruritus


Aliqopa™ (copanlisib) Logo

ALIQOPA  (copanlisib) for injection

Bayer Healthcare Pharmaceuticals

INDICATION: Treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.


  • 72,240 people in US diagnosed with some form of non-Hodgkin lymphoma this year; approximately 20,140 patients will die from disease in 2017
  • Approval provides additional choice for treatment, filling an unmet need


  • Accelerated approval, Priority Review designation, Orphan Drug designation
  • Accelerated approval based on overall response rate; continued approval contingent upon verification of clinical benefit in confirmatory trial
  • Other postmarketing requirements: Long term safety, clinical pharmacology studie
  • Pediatric assessment exemption

MECHANISM OF ACTION:  Inhibitor of phosphatidylinositol-3-kinase with inhibitory activity predominantly against PI3K-α and PI3K-δ isoforms expressed in malignant B cells; induces tumor cell death


  • Single-arm, multicenter, Phase 2 clinical trial, n=142 subjects with relapsed follicular B-cell non-Hodgkin lymphoma
  • Efficacy Endpoints: Tumor response according to the IWG criteria for malignant lymphoma. Overall Response rate (ORR) by Independent Review Committee.
  • ORR: 59%, with median duration of response of 12.2 months


  • Common side effects: Hyperglycemia, diarrhea, decreased general strength and energy, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections, thrombocytopenia
  • Serious side effects: Infections, hyperglycemia, hypertension, non-infectious pneumonitis, neutropenia, severe skin reactions, harm to developing fetus or newborn baby


Image credits: Amgen, SymbiomixBayer








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