New products or new indications
evaluated during the previous year
in the New Products section
of our French edition are eligible
for the Prescrire Drug Awards.

About the 2016 Drug Awards
Each month, the Prescrire Editorial Staff publish comparative systematic analyses of the data available on: drugs newly authorised in France and the EU, new therapeutic indications granted for existing drugs, and existing drugs marketed in a new form or with different packaging. The goal is to help the reader distinguish, among the plethora of new products, those worth adding to their list of useful therapies, those worth using instead of older products, and those to be avoided.

Our analyses are based on rigorous procedures that include a thorough literature search, critical review by a group of reviewers specific to each article, and various quality controls to verify in particular that the text is consistent with all the data available. See > How we work

Total independence
The Prescrire Editorial Staff conduct these analyses free from any industry or institutional influence. Our independence is made possible by the fact that we are financed exclusively by our subscribers, carry no paid advertising in either the French or the English edition, and receive no grants or subsidies of any kind. See  > Financing

The Prescrire Drug Awards are compiled at the end of each year, based on the reviews published that year in our French edition, and taking into account any new data made available since the initial articles were published. These awards honour drugs that constitute a therapeutic advance, in that they offer better efficacy, less frequent or less severe adverse effects (for similar efficacy), or safer or easier administration.

> Download the rules governing the Prescrire Awards (pdf in French)

Two drugs deemed "Noteworthy" in 2016
Two of the products featured in the New Products section of our French edition in 2016 earned a Prescrire Drug Award this year. None of the new products examined constituted a sufficient therapeutic advance to warrant a "Pilule d'Or" (Golden Pill) Award or even a place on the "Honours List".

The two awards were for cancer drugs Prescrire deemed "Noteworthy". They have been shown to prolong survival by a few months on average, but with many serious adverse effects and a few that are sometimes fatal.

Nivolumab (Opdivo°) as monotherapy for some patients
with melanoma or lung cancer
Nivolumab is a monoclonal antibody that stimulates T cell activity in particular, thereby activating the immune response to tumour cells.

In a trial in patients with metastatic or inoperable melanoma whose tumour was negative for the BRAF V600 mutation and who had not yet received treatment for this stage of the disease, nivolumab was far more effective than dacarbazine: the estimated proportion of patients alive after 1 year was about 70% with nivolumab versus about 40% with dacarbazine. Additional evaluation is required however, in particular because dacarbazine, used in Europe until the early 2010s, has not been shown in comparative trials to prolong survival. A direct comparison with ipilimumab, another immunostimulant, would more clearly establish the role of nivolumab in the treatment of these cancers.

In patients with metastatic or inoperable nonsmall cell lung cancer who had already received one line of platinum-containing chemotherapy, nivolumab prolonged median survival by about 3 months and increased the proportion of patients alive after 1 year by about 15% compared with docetaxel, with somewhat fewer serious adverse effects in two non-blinded randomised clinical trials, with consistent results.

Nivolumab can provoke a great variety of sometimes serious adverse effects, generally of immunological origin, in particular: rash, interstitial lung disease, elevated liver enzymes and hepatitis, thyroid disorder, neuropathy and encephalitis. As nivolumab is the first of a new drug class, its adverse effect profile is only partially known.

Trametinib (Mekinist°) combined with dabrafenib
for some patients with melanoma
In patients with metastatic or inoperable BRAF V600-positive melanoma who had not yet been treated for this stage of the disease, the addition of the MEK inhibitor trametinib to first-line treatment with dabrafenib, an inhibitor of the defective BRAF protein, prolonged survival by about 7 months on average compared with BRAF inhibitor monotherapy in two trials with consistent results. The addition of trametinib increases the frequency of serious adverse effects, including heart failure, deep vein thrombosis, bleeding, neutropenia, and gastrointestinal perforation. Trametinib monotherapy has not been shown to constitute a therapeutic advance.

Few therapeutic advances again in 2016
Once again, 2016 provided no major therapeutic advances. The few advances in cancer therapy highlighted in this year's Prescrire Drug Awards are worth noting but rare. This reality is at odds with the hype surrounding the multitude of new products that appear on the market each year and the exorbitant prices charged by pharmaceutical companies for cancer drugs.

©Prescrire February 2017

"The Prescrire Awards 2016" Prescrire Int 2017; 26 (180): 79-83. Pdf, free