EU Panel Likes 4 New Cancer Products

Nick Mulcahy


September 26, 2014

Approval has been recommended for 2 new drugs, one each for non-small cell lung cancer (NSCLC) and gastric cancer, in the European Union (EU).

Marketing authorization has been endorsed by the Committee for Medicinal Products for Human Use (CHMP), the review panel of the European Medicine Agency (EMA).

CHMP also delivered positive assessments of a cancer diagnostic agent for the lymph nodes and a drug for managing chemotherapy-induced neutropenia.

The panel issued one thumbs-down edict, adopting a final negative opinion on a request for an extension of bevacizumab's (Avastin, Roche) indication in the treatment of adult patients with newly diagnosed glioblastoma.

Nintedanib for Lung Cancer

CHMP recommended approval for the oral therapy nintedanib (Vargatef, Boehringer Ingelheim) in combination with docetaxel for the treatment of NSCLC. The indication for this tyrosine kinase inhibitor includes use in locally advanced, metastatic, or locally recurrent NSCLC of adenocarcinoma tumor histology after first-line chemotherapy.

The addition of nintedanib to docetaxel improved progression-free survival and overall survival compared with docetaxel plus placebo, according to clinical trial data.

The most common adverse effects are neutropenia (including febrile neutropenia), decreased appetite, electrolyte imbalance, peripheral neuropathy, bleeding, diarrhea, vomiting, nausea, and increases in alanine aminotransferase, aspartase aminotransferase, and blood alkaline phosphatase. The drug also causes mucositis (including stomatitis) and rash.

Ramucirumab for Gastric Cancer

CHMP recommended the granting of a marketing authorization for the orphan drug ramucirumab (Cyramza, Eli Lilly) for the treatment of adult patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy.

When used in combination with chemotherapy, ramucirumab improved survival compared with chemotherapy alone. The drug also improves survival when used alone and compared with placebo.

The most common adverse effects are fatigue/asthenia, neutropenia, leukopenia, diarrhea, and epistaxis.

Balugrastim for Chemotherapy-Induced Neutropenia

CHMP recommended the granting of a marketing authorization for balugrastim (Egranli, Teva) solution for injection intended for prophylaxis against chemotherapy-induced neutropenia.

The benefits with balugrastim are its ability to reduce the severity of neutropenia and the incidence of febrile neutropenia after the administration of cytotoxic chemotherapy.

The most common adverse effects are musculoskeletal pains, thrombocytopenia, headache, leucocytosis, skin reactions, and increase in liver enzymes.

Lymphoseek for Sentinel Lymph Nodes

Lymphoseek (Navidea Biopharmaceuticals) is indicated for imaging and intraoperative detection of tumor-draining lymph nodes in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. The nodes are also known as sentinel lymph nodes.

External imaging and intraoperative evaluation may be performed with Lymphoseek, using a gamma detection device.

The active substance in Lymphoseek is tilmanocept, a diagnostic radiopharmaceutical that binds to proteins on the surface of macrophages and dendritic cells present in the sentinel lymph nodes.

Final No to Bevacizumab for Glioblastomas

In a previous evaluation, CHMP opined that the effectiveness of bevacizumab in combination with radiotherapy and temozolomide had not been sufficiently demonstrated.

"Although there was an improvement in progression-free survival, it could not be considered clinically relevant because of limitations in the methods available to measure the size of brain tumours. In addition, there was no benefit in terms of overall survival," reads the latest CHMP evaluation.

Full report is available on the EMA's Web site.


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