Pharma approvals and appraisals summary

Image of a selection of medication pots and packs with scientists and patients to show Pharma approvals and appraisals summary

This week’s Pf pharma approvals and appraisals summary includes Roche, Celgene, GSK and Innoviva, Takeda, Novartis and Seqirus.

UK

NICE has published draft guidance that does not recommend polatuzumab vedotin (Polivy, Roche) in combination with rituximab and bendamustine. The combination treatment is not recommended for adults with diffuse large B-cell lymphoma that has relapsed or not responded to primary treatment and who cannot have a haematopoietic stem cell transplant. The guidance is open for consultation until 18 March.

Celgene has announced that NICE has issued a Final Appraisal Document recommending REVLIMID® (lenalidomide) in combination with rituximab (R2) for adults with previously treated follicular lymphoma (grade 1–3A). The announcement means that over 600 patients in England who were previously limited to clinical trials or palliative care, will now have immediate access to a new treatment option with interim funding provided via the Cancer Drugs Fund.

EU

GlaxoSmithKline and Innoviva announced the acceptance of a regulatory submission seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) for the treatment of asthma in adults by the European Medicines Agency.

Takeda has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of a subcutaneous formulation of the gut-selective biologic vedolizumab for use as maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn’s disease. Takeda proposes to make vedolizumab SC available in both a pre-filled syringe and a pre-filled pen.

USA

Novartis announced that both the FDA and EMA have accepted its Supplemental Biologics License Application and Marketing Authorization Application, respectively, for ofatumumab (OMB157) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults. Ofatumumab is a novel B-cell therapy that delivers sustained efficacy with a favorable safety profile.

Seqirus announced that the FDA has approved the first adjuvanted quadrivalent influenza vaccine, FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), to help protect adults 65 years and older against seasonal influenza.

Roche announced that the FDA has accepted the company’s Biologics License Application for the fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous injection in combination with intravenous chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer.

The FDA accepted GSK’s supplemental New Drug Application approval of Zejula (niraparib) as a monotherapy maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. The FDA is reviewing the sNDA under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.


Previous approvals and appraisals

Pharma marketing authorisations, approvals and appraisals – 21 February 2020

Pf’s weekly drug approvals and appraisals – 14 February 2020

Pharma roundup: drug approvals and appraisals – 7 February 2020

Latest pharma drug approvals and appraisals – 31 January 2020

What’s been authorised? UK, Europe, US drug approvals – 24 January 2020