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SMS-oncology

EMA anticancer drug recommendations for approval in 2016

27 January 2017, Canan Karakaya, Pharmacovigilance Manager & Nadina Grosios, Director Consultancy

Among the 81 medicines recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) in 2016, there were 13 recommendations made for novel oncology products (Figure 1), just slightly down from 16 in the previous year. These included immunotherapies, small molecules and even more traditional chemotherapy-based products (Table 1). In the same time period, 18 already approved products received a positive opinion with regards to extending their indication or gaining approval in a new indication (Table 2).

Three new drugs were added to the options available for the treatment of patients with multiple myeloma who have failed previous therapies. These include the two new immunotherapies, elotuzumab and daratumumab, as well as the novel proteosome inhibitor ixazomib. The latter was recommended following resubmission, after having received a negative opinion by the Committee earlier in the year. The two immunotherapies approved for multiple myeloma together with olaratumab, which was approved in combination with doxorubicin for the treatment of adults with advanced soft tissue sarcoma, were the only novel immunotherapies being recommended in 2016.

Cabozantitinib, levantinib and alectinib, being small molecule tyrosine kinase inhibitors, were the more “mainstream” medicines receiving a recommendation. The former two for renal cell cancer and the latter for non-small cell lung cancer.

Three chemotherapies were also recommended for approval by the CHMP; the trifluridine and tipiracil combination for colorectal cancer, liposomal irinotecan for pancreatic cancer and chlormethine for fungoides-type cutaneous T-cell lymphoma. All three medicines have reported statistically significant albeit modest effects in relevant clinical outcomes and hence it remains to be seen how much of an impact they will have in clinical practice.    

On the other hand, palbociclib is set to truly change the clinical landscape in hormone receptor positive and Her2 negative metastatic breast cancer. It has demonstrated remarkable benefits in the first and subsequent lines of treatment; an area where no new approvals have occurred in the last ten years.     

Venetoclax is the first-ever small molecule inhibitor targeting the anti-apoptotic BCL-2 that has received recommendation for approval in EU. It is now indicated as monotherapy for the treatment of chronic lymphocytic leukaemia (CLL) in selected patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, as well as non-selected patients who have failed both chemo-immunotherapy and a B-cell receptor pathway inhibitor.

In terms of existing chemical entities, Truxima, a rituximab biosimilar, received a positive opinion by the CHMP in 2016, making it the first rituximab biosimilar products to be close to approval and marketing in the western world. Positive opinion was also adopted by the CHMP for generic versions of palonosetron, bortezomib and pemetrexed, as well as for the adjunctive T-cell therapy Zalmoxis. The latter is used after haematopoietic stem cell transplant to help restore the patient’s immune system.

Even though there is yet no information about the application of the programmed cell death-ligand 1-targeting antibody atezolizumab, the other checkpoints inhibitors already on the market (pemborlizumab and nivolumab targeting programmed cell death receptor 1) continue to expand their reach in non-small cell lung cancer and melanoma; and nivolumab now also indicated in Hodgkin Lymphoma.      

It is clear that the trend in having increasing number of new products being recommended for approval by the CHMP is continuing and this is undoubtedly good news for patients and their families. It is however worth noting that with the exception of the preventative vaccine Cervarix, and Caprelsa which is indicated for the treatment of medullary thyroid cancer in patients of 5 years or older, all other oncology-related recommendations were for the treatment of cancers in adults. Considering that no paediatric recommendations were made the previous year, this is still an improvement and the trend will hopefully continue.    

 

REFERENCES

European Medicines Agency's (EMA) Website

Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-ositive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16(1):25-35.

Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.

Lessin SR, Duvic M, Guitart J, et al. Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides. JAMA Dermatol. 2013;149(1):25-32.

Mayer RJ, Van Cutsem E, Falcone A, et al. RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015;372(20):1909-19.

Wang-Gillam A, Li CP, Bodoky G, Dean A, et al. NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 ;387(10018):545-57. 

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