NEW APPROVALS BY EMA

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization to an array of anticancer agents, including branded, generic, and biosimiliar products, for marketing approval at its September meeting.

The CHMP recommended niraparib (Zejula, Tesaro) for use in the maintenance treatment of patients with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Niraparib is a poly ADP-ribose polymerase (PARP) inhibitor, but unlike other drugs in this class, it is active both in patients with and those without BRCA mutations. It was approved by the US Food and Drug Administration earlier this year.

The basis of the new approval is the drug's ability to improve progression-free survival (PFS) compared to placebo in this setting. The PFS results from the phase 3 trial known as NOVA are unprecedented. "We have never seen such large benefits in PFS in recurrent ovarian cancer," said lead investigator Mansoor Mirza, MD, of the Copenhagen University Hospital-Rigshospitalet, Denmark, in 2016.

The most common side effects with niraparib are nausea, thrombocytopenia, fatigue/asthenia, anemia, constipation, vomiting, abdominal pain, neutropenia, insomnia, headache, decreased appetite, nasopharyngitis, diarrhea, dyspnea, hypertension, dyspepsia, back pain, dizziness, cough, urinary tract infection, arthralgia, palpitations, and dysgeusia.

Padeliporfin

The CHMP also recommended giving marketing authorization to padeliporfin (Tookad, Steba Biotech) for the initial treatment of low-risk prostate cancer.

Padeliporfin is administered as part of focal vascular-targeted photodynamic therapy and acts as a sensitizer. When activated with laser light, padeliporfin triggers a cascade of pathophysiologic events that result in focal necrosis within a few days, according to the CHMP materials. The therapy improves the likelihood of a negative biopsy result at 24 months and delays disease progression compared with active surveillance.

The most common side effects are urinary and reproductive system disorders.

Trastuzumab Biosimilar

The CHMP also recommended authorization for a trastuzumab biosimilar (Ontruzant, Samsung Bioepis UK Limited) for the treatment of early and metastatic breast cancer and metastatic gastric cancer.

Data show that Ontruzant has comparable quality, safety, and efficacy to Herceptin(trastuzumab, Genentech).

Also, the CHMP recommended authorization for the generic product Imatinib Teva BV, which is for the treatment of leukemia and gastrointestinal stromal tumors.

The new product is a generic form of imatinib (Glivec, Novartis), which is a protein kinase inhibitor. Studies have demonstrated the satisfactory quality of Imatinib Teva BV and its bioequivalence to the reference product, Glivec, according to the CHMP.

The full indication says that Imatinib Teva BV is indicated for the treatment of the following: pediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl)–positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplant is not considered as the first-line of treatment; pediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis; adult patients with Ph+ CML in blast crisis; adult and pediatric patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy; adult patients with relapsed or refractory Ph+ ALL as monotherapy; and adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor gene rearrangements.