Merck have announced their anti-PD-1 therapy for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma has been recommended for approval by the EMA. KEYTRUDA treats urothelial carcinoma in adult patients who have received prior platinum-containing chemotherapy as well as adult patients who are not eligible for cisplatin-containing chemotherapy. A final decision is expected in the third quarter of 2017.

The positive opinion is based on evidence from clinical trials KEYNOTE-045 and KEYNOT-052. The KEYTRUDA clinical development program includes more than 30 tumour types in more than 500 clinical trials. Of these, more than 300 trials use KEYTRUDA in combination with other cancer therapies.

In July 2016, KEYTRUDA received approval by the EMA for the treatment of non-small cell lung carcinoma, as reported in our July 2016 Newsletter.


The EMA has recommended Roche’s immunotherapy Tecentriq for approval. It is indicated for the treatment of advanced bladder and lung cancer. Tecentriq boosts the immune system to find and kill tumours that are difficult to eliminate. It has already been approved by the FDA as first line treatment for bladder cancer. It has also been approved to treat lung cancer.


Janssen Cilag’s Symtuza has been cleared by the EMA for approval of marketing authorisation. Symtuza is a combination therapy containing darunavir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (D/C/F/TAF), and is a new once-daily single tablet regimen (STR) to treat HIV.

It will be the only STR to treat HIV in adults and adolescents aged 12-years and over, with a body weight of 40kg and above. The combination therapy harnesses the efficacy of duranavir (in the form of its high genetic barrier to resistance) together with the improved renal laboratory and bone mineral density profile of F/TAF as compared to F/TDF (tenofovir disoproxil fumarate).

The positive opinion is based on a bioequivalence study comparing the once-daily STR with the combined administration of the separate agents darunavir (D) 800 mg, cobicistat (C) 150 mg, and emtricitabine/tenofovir alafenamide (FTC/TAF) 200 mg/10 mg fixed-dose combination.


The EMA has recommended Novartis’ Rydapt for approval, for the treatment of adults with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive. It will be used in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy. Patients in complete response will also benefit from Rydapt single agent maintenance therapy, as well as adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN) or mast cell leukaemia.


Bayer have announced that the EMA has approved Xarelto in combination with a P2Y12 inhibitor for the treatment of patients with non-valvular atrial fibrillation (AF) who require oral anticoagulation and undergo PCI with stent replacement. The decision follows data from the Phase IIIb PIONEER AF-PCI study which demonstrated that Xarelto 15mg once daily in combination with single anti-platelet therapy significantly reduced the rate of clinically significant bleeding by 41% compared to VKA plus dual antiplatelet therapy (DAPT) in 12 months of randomised therapy.


The EMA has approved the nuclear medicine Lutathera, indicated in the treatment for cancer. It works by harnessing the molecule that is already used to diagnose cancer and to also deliver the treatment. It hits cancer cells with high energy electrons and targets gastroenteropancreatic neuroendocrine tumours (NETs) that over-express a certain protein. Clinical trials have shown encouraging results and the drug maker Advanced Accelerator Applications hope to receive full approval before the end of the year.


The EMA has validated CTI BioPharma Corp’s pacritinib, for the treatment of patients with myelofibrosis who have thrombocytopaenia.

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses.

Bictegravir, Emtricitabine and Tenofovir Alafenamide:

The EMA has approved Gilead Sciences Inc’s. bictegravir, a oncedaily single tablet regimen containing 50mg bictegravir and emtricitabine/tenofovir alafenamide (200/25mg; FTC/TAF) for the treatment of HIV-1 infection. Phase III clinical trials over 48 weeks have shown the drug’s virological suppression capabilities as well as no treatment-emergent resistance among treatment naïve adult patients. It also showed these effects in virologically suppressed adult patients who switched regimens.


Ipsen’s Cabozantinib has been approved by NICE in England and Wales, for the treatment of patients with advanced kidney cancer. It can prolong the life of patients by inhibiting the growth of new blood vessels within a tumour, consequently preventing its spread.

This new treatment approved for use on the NHS in England and Wales could prolong the life expectancy of patients with advanced kidney cancer, according to experts.

Patients with advanced renal cell carcinoma (RCC) could benefit as this new treatment offers an increased chance of improved, progression-free survival. It is an important milestone for this kind of drug as it is one of the few that extends survival.

According to Cancer Research UK, kidney cancer is the 7th most common cancer in the UK (excluding non-melanoma skin cancer) with around 12,500 kidney cancers being diagnosed in the UK in 2014.