Anticancer Medicines Recommended for Approval by EMA in 2014

Number of medicines with new active substances continues to increase

In 2014, eight new medicines for cancer were recommended for marketing authorisation by the European Medicines Agency (EMA), of which four target rare cancers.

In particular, the EMA recommended approval  of vintafolide in ovarian cancer, trametinib in melanoma, obinituzumab in chronic lymphocytic leukaemia (CLL), ibrutinib for mantle cell lymphoma and CLL, idelalisib for CLL and follicular lymphoma, nintedanib for non-small cell lung cancer (NSCLC), ramucirumab in gastric cancer and cancer of gastro-oesophageal junction, and olaparib for ovarian cancer.

In addition, the EMA approved biosimilar filgrastim for the management of febrile neutropenia in patients treated with cytotoxic chemotherapy.

Furthermore, in 2014 the EMA extended indications for sorafenib to thyroid cancer, denosumab to giant cell tumour of bone, changed indication for eribulin in breast cancer, extended indications for HPV vaccines to prevention of anal carcinoma,  extended indications of ofatumumab in CLL, extended indications of regorafenib to gastrointestinal stromal tumours (GIST), extended indications of bevacizumab to ovarian cancer, fallopian tube and peritoneal cancer, extended indications of enzalutamide in prostate cancer, extended indications of bortezomib to mantle cell lymphoma, and extended indications of lenalidomide in multiple myeloma. 

Ovarian cancer 

On 20 March 2014, the EMA recommended granting a marketing authorisation for vintafolide for the treatment of adult patients with platinum-resistant ovarian cancer that express the folate receptor on all target lesions. It has recommended approval for vintafolide together with the approval of two companion diagnostic medicines, etarfolatide and folic acid that will help identify patients who may benefit from treatment with vintafolide. All three of these medicines have an orphan designation and were recommended for conditional marketing authorisations.

On 26 June 2014, the EMA adopted a positive opinion recommending a variation to the terms of the marketing authorisation for bevacizumab. It adopted a new indication as follows: bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. 

On 23 October 2014, the EMA recommended granting a marketing authorisation for olaparib as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.

Melanoma 

On 25 April 2014, the EMA recommended granting a marketing authorisation for trametinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Thyroid carcinoma

On 25 April 2014, the EMA recommended adding a new indication to the use of sorafenib to treat patients with papillary/follicular/Hürthle cell thyroid carcinoma, refractory to radioactive iodine.

Haematological medicines

On 22 May 2014, the EMA recommended granting a marketing authorisation for obinutuzumab for the treatment in combination with chlorambucil of adult patients with previously untreated CLL and comorbidities making them unsuitable for full-dose fludarabine based therapy. 

On 22 May 2014, the EMA adopted a positive opinion recommending a variation to the terms of the marketing authorisation for ofatumumab. In combination with chlorambucil or bendamustine, it is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.

On 24 July 2014, the EMA recommended granting a marketing authorisation for ibrutinib intended for the treatment of adult patients with relapsed or refractory mantle cell lymphoma for the treatment of adult patients with CLL who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

On 24 July 2014, the EMA recommended granting a marketing authorisation for idelalisib in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. It is indicated as monotherapy for the treatment of adult patients with follicular lymphoma that is refractory to two prior lines of treatment. 

On 18 December 2014, the EMA adopted a positive opinion recommending a variation to the terms of the marketing authorisation for bortezomib. The EMA adopted a new indication as follows: bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation. 

On 18 December 2014, the EMA adopted a positive opinion recommending a variation to the terms of the marketing authorisation for lenalidomide. It adopted a new indication as follows: lenalidomide is indicated for the continuous treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Supportive care

On 25 April 2014, the EMA adopted a positive opinion recommending a variation to the terms of the marketing authorisation for denosumab. It adopted a new indication for the treatment of osteoporosis in men at increased risk of fractures. It also added that in postmenopausal women denosumab significantly reduces the risk of vertebral, non vertebral and hip fractures.

On 24 July 2014, the EMA recommended granting a marketing authorisation for biosimilar filgrastim (Accofil) for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Accofil are similar in adults and children receiving cytotoxic chemotherapy.

Breast cancer

On 22 May 2014, the EMA adopted a positive opinion recommending a variation to the terms of the marketing authorisation for product eribulin. It is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.

Cancer prevention

On 25 April 2014, the EMA adopted a positive opinion recommending a variation to the terms of the marketing authorisation for two Human Papillomavirus (HPV) vaccines, Gardasil and Silgard. The EMA adopted extension of indication to prevention of premalignant anal lesions and anal cancers causally related to certain oncogenic HPV types.

GIST 

On 26 June 2014, the EMA adopted a positive opinion recommending a variation to the terms of the marketing authorisation for regorafenib. The EMA adopted a new indication as follows: treatment of adult patients with unresectable or metastatic GISTs who progressed on or are intolerant to prior treatment with imatinib and sunitinib.

Bone tumours

On 24 July 2014, the EMA adopted a positive opinion recommending a variation to the terms of the marketing authorisation for denosumab. The extended indication concerns treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Lung cancer 

On 25 September 2014, the EMA recommended granting a marketing authorisation for the nintedanib intended in combination with docetaxel for the treatment of locally-advanced, metastatic or locally-recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy.

Gastric cancer

On 25 September 2014, the EMA recommended granting a marketing authorisation for ramucirumab intended for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy.

Prostate cancer

On 23 October 2014, the EMA adopted a positive opinion recommending a variation to the terms of the marketing authorisation for enzalutamide. It adopted a new indication as follows: enzalutamide is indicated for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.