SMC ACCEPTS LYNPARZATM (OLAPARIB) FOR USE IN SCOTLAND FOR BRCAMUTATED PROSTATE CANCER1

SMC ACCEPTS LYNPARZATM (OLAPARIB) FOR USE IN SCOTLAND FOR BRCAMUTATED

PROSTATE CANCER1

• Men in Scotland will be the first in the UK to gain NHS access to olaparib for the treatment

of metastatic castration-resistant prostate cancer (mCRPC) with BRCA1 or BRCA2 gene

mutations.1

• Olaparib is the only targeted treatment licensed in the UK for mCRPC, an aggressive,

hard-to-treat form of prostate cancer with an average life expectancy of 13 months.2

• In men with BRCA-mutated mCRPC, clinical trial data show that olaparib reduced the

risk of disease progression or death by 78% compared to a second new hormonal agent

and increased overall survival (20.1 months versus 14.4).3

• Prostate cancer affects one in 10 men in Scotland and rates are increasing.4

• A blood or tumour sample test is required to confirm BRCA status before starting

treatment.

Luton, UK, 11 October 2021 – Today, AstraZeneca and MSD announced that the Scottish

Medicines Consortium (SMC) has accepted the oral targeted cancer therapy, Lynparza

(olaparib), for use within NHS Scotland as monotherapy for the treatment of adult patients with

metastatic castration-resistant prostate cancer (mCRPC) and BRCA1 or BRCA2 gene

mutations (germline and/or somatic) who have progressed following prior therapy that

included a new hormonal agent (NHA).1

Every year, 900 men die of prostate cancer in Scotland, where it is the most common cancer

among men.4,5 mCRPC is an advanced, incurable form of the disease that no longer

completely responds to medical or surgical treatment options that lower testosterone.6 Around

one in 10 men with mCRPC could have BRCA gene mutations in their tumours, detected

through a genomic blood or tumour sample test.7 Up to 62 men with BRCA-mutated mCRPC

in Scotland could be eligible for treatment with olaparib every year.

Commenting on today’s announcement, Rob Jones, Professor of Clinical Cancer

Research at the University of Glasgow, said: “This is an important moment for the treatment

of prostate cancer in Scotland. For the first time, men with advanced castration-resistant

prostate cancer now have access to a ‘precision medicine’, whereby treatment is selected on

the basis of a genetic test - in this case, an abnormal BRCA gene. For these men, olaparib

could delay the need for chemotherapy and extend survival, potentially making a real

difference to their lives. It is now essential that men with this type of prostate cancer have

access to BRCA testing to determine their eligibility for treatment.”

The SMC decision was based on data from the PROfound clinical trial, in which olaparib reduced

the risk of disease progression or death by 78% compared to investigators choice of NHA, in

men with BRCA-mutated mCRPC who had previously been treated with an NHA (based on a

hazard ratio [HR] of 0.22, 95% confidence interval [CI], 0.15-0.32; nominal p<0.0001, results not

controlled for multiplicity).1,3 Treatment with olaparib delayed progression of the disease to a

median of 9.8 months compared to 3.0 months when treated with an NHA.3 Risk of death was

reduced by 37% (HR 0.63, 95% CI 0.42-0.95) with median overall survival of 20.1 months versus

14.4 months when treated with an NHA (results are nominally statistically significant).3

Cancer cells with ‘faulty’ BRCA1 or BRCA2 genes rely on a protein called PARP (poly-ADP

ribose polymerase) to repair themselves when they get damaged.8 Olaparib, a PARP inhibitor,

exploits this repair pathway by blocking PARP so the cancer cells are unable to self-repair,

causing them to die.8

To determine eligibility for treatment with olaparib, patients with mCRPC must be tested to

determine whether they harbour BRCA mutations. While blood tests for BRCA are available

to men who meet certain criteria, tumour sample tests for BRCA are not widely available. This

could mean that potentially half of mCRPC patients who have BRCA mutations will not be

identified and could therefore miss out on treatment.9

Steve Allen, Patient Representative at Tackle Prostate Cancer, said: “Prostate cancer is

often perceived to be a disease that, given appropriate treatment, men usually die with, and

not from. However, metastatic castration-resistant prostate cancer is an aggressive form of

the disease, with limited treatment options and a poor prognosis. This SMC decision marks

an important change in the treatment of mCRPC in Scotland, moving us into a new era of

personalised medicine that we hope will make a meaningful difference to the lives of these

men and their loved ones.”

Arun Krishna, Head of Oncology at AstraZeneca UK, said: “Olaparib was discovered and

developed in the UK and it is wonderful news that the SMC has agreed to make it available

for men with mCRPC in Scotland. It is now vital that all men with mCRPC have access to

BRCA testing to help their doctor determine whether this is a treatment option for them. The

Scottish Government has committed to investing in the genetic labs and frontline genetics

services required to embed genomics medicine into routine healthcare, and the SMC

acceptance of olaparib is an important opportunity to demonstrate delivery on this commitment

for patients in Scotland.”

David Long, UK Oncology Business Unit Director, MSD UK said: “The availability of

olaparib for men with BRCA-mutated mCRPC is an important step forward in treating this

aggressive disease. These patients tend to be younger than the average prostate cancer

patient and sadly face a poorer prognosis. Achieving NHS access for these patients is a major

priority for MSD and AZ and, now we have secured access in Scotland, we will continue to

focus our efforts on securing access for patients across the rest of the UK.”

Olaparib is indicated as monotherapy for the treatment of adult patients with metastatic

castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who

have progressed following prior therapy that included a new hormonal agent.

Adverse events (AEs) in the PROfound trial were generally consistent with the recognised

safety profile of olaparib.3 Based on pooled data from 2901 patients with solid tumours treated

with olaparib monotherapy in clinical trials, very common AEs include: anaemia, neutropenia,

thrombocytopenia, leukopenia, decreased appetite, dizziness, headache, dysgeusia, cough,

dyspnoea, vomiting diarrhoea, nausea, dyspepsia and fatigue (including asthenia). Common

AEs include lymphopenia, stomatitis, upper abdominal pain, rash and increase in blood

creatinine.3

For further information about olaparib, including the complete list of licensed indications, side

effects and adverse reactions, please refer to the summary of product characteristics:3

https://www.medicines.org.uk/emc/product/9204/smpc.