Roche And Shionogi Aim For EU Accelerated Assessment
Executive Summary
Roche will learn this week if two potential anticancers it is developing - polatuzumab vedotin and entrectinib - will be okayed for fast track regulatory review when they are filed in the EU.
Roche, Shionogi and Karyopharm Therapeutics are among the companies that will this week learn whether their products will be accepted for fast-track regulatory review by the European Medicines Agency. The agency’s Committee for Medicinal Products for Human Use will decide whether the products make the grade for accelerated assessment at its December meeting, which is under way in London.
Roche will get news on two products.
The first is polatuzumab vedotin for treating diffuse large B cell lymphoma (DLBCL), which is the most common aggressive form of non-Hodgkin lymphoma. It is being assessed for fast-track review for patients with relapsed and refractory DLBCL.
The company’s other iron in the fire is entrectinib. This is under review for treating patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive locally advanced or metastatic solid tumours following prior treatment, or as initial therapy if there are no acceptable standard therapies. In addition, the CHMP will be examining its potential under the accelerated assessment scheme as a treatment for patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC).
Roche won its first ever EU priority medicine designation when polatuzumab vedotin in combination with MabThera (rituximab) and bendamustine was accepted on to the EMA’s PRIME scheme in June 2017. This scheme aims to get products for unmet need to patients faster. (Also see "EMA Says Yes To First Sickle Cell Drug For PRIME" - Pink Sheet, 30 Jun, 2017.)
In April 2018, it won an orphan designation for polatuzumab vedotin from the European Commission.
As for entrectinib, Roche acquired the product when it completed its $1.7bn purchase of Ignyta in February.
Also on the list of drugs under consideration for fast-track review is Karyopharm’s selinexor, in combination with dexamethasone, for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and to their most recent treatment regimen.
In 2015 selinexor was granted EU orphan designation for the treatment of multiple myeloma. In the US, a new drug application for oral selinexor with low dose dexamethasone for patients with penta-refractory multiple myeloma is undergoing priority review at the Food and Drug Administration, with an action date under the Prescription Drug User Fee Act slated for next April.
Meanwhile, Shionogi’s cefiderocol is also up for consideration in two indications: treatment of infections caused by carbapenem-resistant Gram-negative bacteria in adults with limited treatment options and also infections caused by aerobic Gram-negative bacteria in adult patients with limited treatment options.
Also under consideration for accelerated assessment is arsenic trioxide for induction of remission, and consolidation in adult patients with:
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Newly diagnosed low-to-intermediate risk acute promyelocytic leukemia (APL) in combination with all-trans-retinoic acid; and
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Relapsed/refractory APL (where previous treatment should have included a retinoid and chemotherapy) characterized by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene.
The EMA’s accelerated assessment procedure is a fast-track mechanism that can reduce the timeline from 210 to 150 days for conducting the review of a marketing authorization application under the EU centralized procedure. Medicines under consideration must be of major interest for public health or should be considered a therapeutic innovation. Accelerated assessment requests are usually made two or three months before marketing authorization applications are submitted.
The outcomes of accelerated assessment requests are published in the minutes of the CHMP meeting at which the requests are decided on. While companies themselves sometimes disclose the outcome earlier, they tend not to. It usually takes at least six weeks for CHMP meeting minutes to be published.
From the editors of Scrip Regulatory Affairs