A microscopy image showing ball of prostate cells expressing a potential new marker (red) for aggressive prostate cancer.

Image credit: Dr Esther Baena, CRUK Manchester Institute.

The National Institute for Health and Care Excellence (NICE) has approved apalutamide (Erleada) in combination with a hormone treatment for some prostate cancer patients in England.

The hormone therapy will now be an option for adults with advanced hormone-sensitive prostate cancer that’s spread to other parts of the body.

According to NICE, the drug could help stop the spread of prostate cancer and should be used if the chemotherapy docetaxel is not suitable or can’t be tolerated.

Kruti Shrotri, head of policy development at Cancer Research UK said: “This is good news for people affected by this type of prostate cancer. Many patients can’t tolerate or choose not to have chemotherapy due to its impact on their quality of life, and they will now have another potentially life-extending treatment option available to them.”

A new combination

Apalutamide works by blocking the effect of testosterone on prostate cancer cells and will be available for some 8,000 people in England.

In the TITAN clinical trial, patients who were given apalutamide and androgen deprivation therapy (ADT) were found to live longer than those treated with a dummy drug (placebo) plus ADT.

Studies also found that apalutamide with ADT is more effective than using ADT alone. Although no trials directly comparing the two have been done, indirect analysis of the data by researchers has shown that the apalutamide treatment combination was better tolerated than docetaxel plus ADT.

Additional treatment options

Patients have gradually seen more treatments become accessible – often a combination therapy involving ADT, chemotherapy and steroids.

Until this year, many people with few or no symptoms of prostate cancer may have chosen to take ADT alone. Despite the long-term benefits of docetaxel, their decision is often based on the belief that the medicine worsens quality of life.

In June this year, the committee green-lit enzalutamide (Xtandi) plus ADT, as a treatment option for patients with this type of prostate cancer.

And during the COVID-19 pandemic a new option was added, as NHS England published interim guidance, allowing patients to be treated with the medicines abiraterone and prednisone plus ADT. However, due to the cost of abiraterone, the treatment is only used for people who cannot tolerate enzalutamide plus ADT.

Following the latest NICE decision, patients will also have access to a ‘valuable’ new treatment option, which patient experts noted is generally better tolerated than chemotherapy.

NICE decisions are usually adopted in Wales and Northern Ireland, while Scotland has a separate process for reviewing drugs.

A campaign for change

Cost played a role in apalutamide’s journey to approval.

In draft guidance published earlier this year, NICE decided against recommending apalutamide due to uncertainties in the clinicial trial results – because patients could switch medication from the placebo to apalutamide during trials. However, they also concluded that cost estimates were uncertain and too high to be considered an acceptable use of NHS resources.

The decision prompted a Prostate Cancer UK campaign calling on NICE and the medicine’s manufacturer Janssen to give patients access to apalutamide. This latest decision comes as the pharmaceutical company has agreed an undisclosed discount on the drug for the NHS.

“We are very pleased that Janssen has been able to work with us to address the uncertainties in the evidence identified by the committee in the previous draft guidance,” said Meindert Boysen, NICE deputy chief executive and director of the centre for health technology evaluation. “This means that we are able to produce final draft guidance recommending apalutamide as an effective and valuable additional treatment option for people with these types of prostate cancer.”