EMA-recommendations-primeoncology_2017

EMA Positive Opinions to Expand Oncology Treatment Options in Europe

In March and April 2018, the European Medicines Agency (EMA) issued several positive opinions that recommended approval or expanded indications for oncology/hematology agents. All but one of these agents has been previously approved by the US Food and Drug Administration (FDA) for similar indications.

Osimertinib for First-Line EGFR-Mutant NSCLC. The EMA granted a positive opinion for the approval of osimertinib (Tagrisso®, AstraZeneca) for first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor (EGFR) mutations. In the phase III FLAURA trial, osimertinib improved progression-free survival (PFS) by 8.7 months, compared to erlotinib or gefitinib.

Pertuzumab and Trastuzumab Combo for HER2-Positive Early Breast Cancer. The EMA endorsed expanding the indication of pertuzumab (Perjeta®, Roche) to include use in combination with trastuzumab (Herceptin®, Roche) and chemotherapy for adjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer at high risk for recurrence. In the phase III APHINITY trial, the combination of pertuzumab and trastuzumab with chemotherapy resulted in a 19% reduction in the risk of recurrence or death, compared to trastuzumab plus chemotherapy in patients with node-positive or high-risk node-negative HER2-positive early breast cancer.

A third biosimilar version of trastuzumab (Kanjinti®, Amgen) received a positive opinion for use in place of Herceptin® in all indications for which Herceptin® is currently approved, including use in the adjuvant setting. This agent is not approved in the United States.

First-Line Cabozantinib Recommended for Intermediate-/Poor-Risk Renal Cell Carcinoma. The indication of cabozantinib (Cabometyx®, Ipsen Pharma) in advanced renal cell carcinoma (RCC) was expanded to include use in treatment-naïve patients with intermediate or poor-risk disease. This positive opinion was based on results from the randomized phase II CABOSUN trial, in which cabozantinib significantly improved PFS, compared to sunitinib (8.2 months vs 5.6 months; HR 0.66, P = .012) in treatment-naïve patients with intermediate-/poor-risk advanced RCC.

Rucaparib for Pretreated BRCA-Mutated Ovarian Cancer. Rucaparib (Rubraca®, Clovis) received a positive opinion for conditional approval as a monotherapy for treatment of patients with relapsed or progressive ovarian cancer with a BRCA mutation. This approval is based on objective response rate and duration of response from two single-arm trials, study 10 and ARIEL 2. In the United States, rucaparib has been available for this indication since December 2016.  It was recently approved for use as maintenance therapy following platinum chemotherapy in patients with recurrent ovarian cancer, regardless of BRCA mutation status.

Treatment of Pediatric Chronic Myeloid Leukemia with Dasatinib. The EMA issued a positive opinion regarding expansion of the indication for dasatinib (Sprycel®, Bristol-Myers Squibb) to include pediatric patients with Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML) in chronic phase. A new formulation of dasatinib as a powder for oral suspension will be used in pediatric patients.

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