SMC nod for Novartis’ Kisqali, MSD’s Keytruda

Novartis’ Kisqali (ribociclib) was accepted for the treatment of advanced breast cancer in postmenopausal women, after having been considered through the SMC’s Patient and Clinician Engagement (PACE) process for medicines used to treat very rare and end of life conditions.

The SMC said it was highlighted during the PACE meeting that Kisqali can increase the period of time patients have until their condition progresses and as an oral treatment is easy to administer.

The drug won European approval in August last year on the back of data showing that when added letrozole the risk of progression or death was cut 43 percent over the latter drug alone, and reduced tumour burden with a 53 percent overall response rate.

Kisqali has also been accepted for NHS use in England and Wales, following an agreement between the drugmaker and the National Institute for Health and Care Excellence.

Also accepted through PACE was MSD’s Keytruda (pembrolizumab) for the treatment of advanced Hodgkin’s lymphoma in patients who have failed to respond to previous treatments.

The only current treatment option for patients is chemotherapy, which offers a poor response rate and causes substantial side effects, patient representatives stressed at the PACE meeting.

Keytruda "may provide a bridge to transplant with the prospect of a cure, while for others it may provide a long lasting remission with fewer side effects than chemotherapy," the SMC noted.

The endorsement contrasts with NICE’s position, which said earlier this week that it was minded not to recommend Keytruda in this setting after concluding that its cost effectiveness was too uncertain.

In draft guidelines, the Institute rejected the drug’s use for relapsed or refractory classical Hodgkin lymphoma in adults unable to have an autologous stem cell transplant who failed treatment with brentuximab vedotin, but is still considering whether it can be used in patients who have had both the transplant and prior treatment.

The SMC said it was unable to accept Roche’s Tecentriq (atezolizumab) for advanced bladder cancer in patients unable to receive the current preferred treatment for this stage of the disease, because of uncertainties in the evidence submitted.

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