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03-10-2017 | EMA | Drug approval | News

approvalsWatch

Niraparib, padeliporfin receive EMA nod

medwireNews: The European Medicines Agency (EMA) has recommended that a marketing authorization be granted to niraparib and padeliporfin for the treatment of ovarian cancer and adenocarcinoma of the prostate, respectively.

Niraparib – a poly(ADP-ribose) polymerase (PARP) inhibitor – is indicated for the maintenance treatment of women with relapsed, high-grade, serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have achieved a complete or partial response to platinum-based chemotherapy.

The PARP inhibitor was approved on the basis of clinical trial results showing improved progression-free survival compared with placebo in this patient population.

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Padeliporfin is a sensitizer used in photodynamic or radiation therapy, and following this positive opinion can be administered as part of focal vascular-targeted photodynamic therapy to patients with treatment-naïve, unilateral, low-risk prostate adenocarcinoma who have a life expectancy of at least 10 years.

The documentation clarifies that low-risk disease is categorised by the following features:

  • Clinical stage T1c or T2a;
  • Gleason score of 6 or below;
  • Prostate-specific antigen (PSA) levels of 10 ng/mL or lower;
  • Three positive cancer cores, each no larger than 5 mm, or 1–2 positive cancer cores with at least 50% cancer involvement in any one core or a PSA density of at least 0.15 ng/mL per cm3.

In clinical trials, padeliporfin administration improved the likelihood of having a negative biopsy at the 24-month mark and delayed disease progression relative to active surveillance.

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

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