dm+d

432885003

New Medicines

LynparzaMetastatic pancreatic cancer, gBRCA mutated - maintenance monotherapy in adults whose disease has not progressed on first line platinum based chemotherapy

Information

Lynparza
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Launched
Launched
Launched
July 2020
Yes
Jul 20Approved in EU [15]
May 20Recommended for EU approval by CHMP - the additional indication is "as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen." [14].
Dec 19Olaparib has been approved in the US for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen [13].
Sep 19Has been filed in the EU & US [12].
Jun 19Filings planned Q2 2019. Filings will be based on results of PIII POLO trial [10,11].
Oct 18Granted orphan drug designation in the US [5]
Sep 18Filing based on POLO planned for H2 19 [4].
Jun 17EU filing will be via centralised procedure [3].
May 16EU & US filings planned for 2018 [1].
Mar 15PIII starts [1].

Category

A potent inhibitor of human poly (ADP ribose) polymerase enzymes (PARP 1, PARP 2, and PARP 3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo. First-in-class.
Pancreatic cancer affects approximately 45,300 patients at any given time in the European Union and has a prevalence of approximately 0.88 per 10,000.
Metastatic pancreatic cancer, gBRCA mutated - maintenance monotherapy in adults whose disease has not progressed on first line platinum based chemotherapy
Oral

Further information

Yes

Trial or other data

Jun 19PIII POLO RCT (NCT02184195; n=154) reported improved median progression-free survival with maintenance olaparib vs placebo (7.4 vs. 3.8 months; HR, 0.53; P=0.004) but with a higher incidence of grade 3 or higher adverse events (40% vs 23%) [8].
Feb 19Positive topline data announced from PIII randomised, double-blinded, placebo-controlled, multi-centre POLO trial ((NCT02184195, n=154) in which pts were randomised (3:2) to receive Lynparza (300mg BD) or placebo until the disease progressed. The company announced that the primary endpoint was met with statistically significant and clinically meaningful improvements in Progression Free Survival [PFS] vs. placebo. Full data wfrom the study are not yet published.[7]
Sep 18PIII POLO study (NCT02184195) is still recruiting & now expects to complete collection of primary outcome data in Jan 19 [6].
Jan 17NCT02184195 still aiming for Oct 17 completion.
Dec 14PIII POLO study starts (NCT02184195). This is a PIII study of maintenance olaparib monotherapy in patients with gBRCA mutated metastatic pancreatic cancer whose disease has not progressed on first line platinum based chemotherapy. 145 adults will be recruited from sites globally including the US & EU (incl UK). Primary outcome is PFS; collection of data should complete Oct 17 [2].

Evidence based evaluations

LynparzaBRCA1/2 or ATM gene-mutated metastatic castration resistant prostate cancer (mCRPC) - third-line monotherapy

Information

Lynparza
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Launched
Launched
Pre-registration (Filed)
November 2020
Nov 20Approved in the EU as monotherapy for treatment of adults with BRCA1/2-mutated metastatic castration-resistant prostate cancer [22].
Sep 20Recommended for EU approval by CHMP - the additional indication is "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" [21].
Jan 20FDA grants priority review for olaparib for HRR-mutated metastatic castration-resistant prostate cancer [16].
Dec 19Filing to the EMA has been made [15].
Dec 19Filings delayed to H1 20 [14].
Sep 19Filings now expected H2 19 [13].
Sep 18Filings planned for 2020 or later [8].
Jun 17EU filing will be via centralised procedure [6].
Mar 17Pivotal, global PIII PROfound study starts [5].
Jan 16Granted breakthrough therapy designation in US based on results of TOPARP-A [2].

Category

A potent inhibitor of human poly (ADP ribose) polymerase enzymes (PARP 1, PARP 2, and PARP 3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo. First-in-class.
Prostate cancer is the most common cancer in men and makes up 26% of all male cancer diagnoses in the UK. The age-standardised incidence of prostate cancer in the UK in 2010 was 104.5 per 100,000 population [3]
BRCA1/2 or ATM gene-mutated metastatic castration resistant prostate cancer (mCRPC) - third-line monotherapy
Oral

Further information

Yes

Trial or other data

Feb 22Analysis of PIII PROfound study (n=245) prespecified secondary endpoints found olaparib linked to reduced pain burden & better-preserved health-related quality of life vs. control [23].
Sep 20Data on survivial in the PIII PROfound study is published. Among 387 men whose disease had progressed during previous treatment with a next-generation hormonal agent, those initially assigned to olaparib had longer overall survival vs those assigned to enzalutamide or abiraterone plus prednisone (17.3 vs 14.0 months, respectively) [20].
Apr 20PIII PROfound study (n=387) is published; it found superior progression free survival for olaparib vs abiraterone or enzalutamide (7.4 vs 3.6 months, HR for progression or death 0.34, 95% CI 0.25-0.47) in this population with disease progression while receiving a new hormonal agent [17].
Apr 20AstraZeneca report further positive results from the PIII PROfound trial. Results showed a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS) with olaparib vs enzalutamide or abiraterone [19].
Oct 19MSD and AstraZeneca report risk of disease progression or death (primary endpoint) was reduced by a median of 7.4 months vs 3.6 months with placebo in PIII PROfound study (n=387) [12].
Aug 19PIII PROfound study (NCT02987543) has announced that olaparib met its primary endpoint, showing a statistically significant and clinically-meaningful improvement in terms of radiographic progression-free survival versus enzalutamide or abiraterone [11].
Dec 18PROfound data anticipated H2 19 [10].
Jun 18PIII PROfound study (NCT02987543) is due to complete collection of primary outcome data in Mar 20 [9].
Jun 17First pt commenced dosing in PROfound PIII study [7].
Jan 17NCT02987543 PROfound PIII study trial to evaluate olaparib 150mg tablet bid versus enzalutamide or abiraterone acetate in patients with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations is not yet enrolling but UK recruitment is planned [4]
Jan 16Results of TOPARP-A indicate that olaparib could offer substantial improvement over available therapies [2].
Jul 12PII trial (NCT01682772; TOPARP) initiated to investigate the efficacy and tolerability of olaparib in patients with advanced castration-resistant prostate cancer. The trial will enrol approximately 89 patients in the UK [1].

Evidence based evaluations

LynparzaAdvanced ovarian cancer - first-line maintenance in combination with bevacizumab

Information

Lynparza
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Launched
Launched
Launched
November 2020
Nov 20Approved in EU for use in combination with bevacizumab as first-line maintenance treatment for HRD-positive advanced ovarian cancer [15].
Sep 20The full new indication proposed by the EU CHMP is use in combination with bevacizumab for maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability [14].
Sep 20Olaparib recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer [13].
May 20Approval in the US is restricted only to use in patients with homologous recombination deficiency (HRD) positive tumours (defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability). About half of women with advanced ovarian cancer have an HRD-positive tumour [12].
May 20Approved in the US. [11]
Jan 20Filed in US. [10]
Dec 19Filings has been made to the EMA [9].
Dec 19Filings now expected H1 20 [8].
Sep 19Filings based on PAOLA-1 planned for H2 19 [5].

Category

A potent inhibitor of human poly (ADP ribose) polymerase enzymes (PARP 1, PARP 2, and PARP 3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo. First-in-class.
Ovarian cancer affects approximately 2.9 in 10,000 people in the EU (equivalent to around 144,000 people) [1].
Advanced ovarian cancer - first-line maintenance in combination with bevacizumab
Oral

Further information

Yes

Trial or other data

May 20US approval was based on a biomarker subgroup analysis of 387 patients with HRD-positive tumours from the PIII PAOLA-1 trial, which showed that olaparib in combination with bevacizumab reduced the risk of disease progression or death by 67% (HR 0.33 [95% CI, 0.25-0.45]). It improved PFS to a median of 37.2 months vs. 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer [12]
Dec 19PIII PAOLA-1 trial (NCT02477644; n=806) is published in the NEJM; it found addition of maintenance olaparib to bevcizumab provided a significant progression-free survival benefit vs. addition of placebo (22.1 vs. 16.6 months, HR 0.59; 95% CI, 0.49-0.72; p<0.001), which was greater in patients with HRD-positive tumours [7].
Oct 19PIII PAOLA-1 trial significantly increased PFS as 1st line maintenance treatment with bevacizumab for newly-diagnosed advanced ovarian cancer. The trial compared olaparib when added to SoC bevacizumab versus bevacizumab alone in women in the 1st line maintenance setting, irrespective of genetic biomarker status or outcome from previous surgery. Olaparib and bevacizumab reduced the risk of disease progression or death by 41% and improved PFS to a median of 22.1 months versus 16.6 months for those treated with bevacizumab alone (HR 0.59 [95% CI, 0.49-0.72], p<0.0001) [4].
Aug 19PIII PAOLA-1 study is ongoing but no longer recruiting [2].
May 15PIII PAOLA-1 study starts (NCT02477644). 806 patients with advanced FIGO stage IIIB - IV high grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer will be randomised to olaparib or placebo plus standard first-line treatment, combining platinum-taxane chemotherapy and bevacizumab concurrent with chemotherapy and in maintenance. the study will recruit from sites in Europe (not UK). Collection of primary outcome data (progression-free survival) will complete Jun 22 [2,3].

Evidence based evaluations

LynparzaEarly breast cancer, BRCA1/2 mutations and high risk HER2 negative - adjuvant

Information

Lynparza
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Phase III Clinical Trials
Recommended for approval (Positive opinion)
Launched
Jun 22Recommended for EU approval by CHMP – the extension to the existing indication is for use as “monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy” [6].
Mar 22Olaparib approved in US by FDA for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery [19]
Feb 22Is now pre-registration in EU, based on data from OlympiA [18].
Nov 21Granted Priority Review in the US. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2022 [17]
Nov 21Filed in US [16].
Feb 21 Filings planned for H2 2021 [13]
Sep 19Filings now planned for 2021 [9].
Sep 18Filings still expected 2020 or later [7].
Jun 17EU filing will be via centralised procedure [6].
Jun 14EU & US filings planned for 2020 [1].
May 14PIII study commences [1].

Category

A potent inhibitor of human poly (ADP ribose) polymerase enzymes (PARP 1, PARP 2, and PARP 3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo. First-in-class.
BRCA1 and BRCA2 mutations account for about 20 to 25 percent of hereditary breast cancers and about 5 to 10 percent of all breast cancers [3].
Early breast cancer, BRCA1/2 mutations and high risk HER2 negative - adjuvant
Oral

Further information

Yes

Trial or other data

Mar 22Positive results from OlympiA trial demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo. In the key secondary endpoint of OS, olaparib reduced the risk of death by 32% versus placebo (based on a HR of 0.68; 98.5% CI 0.47-0.97; p=0.009). Olaparib improved the three-year survival rate to 92.8% versus 89.1% for those on placebo.The safety and tolerability profile in this trial was in line with that observed in prior clinical trials [20]
Jun 21PIII OlympiA study (n=1,836) found olaparib, given after completion of local treatment and neoadjuvant or adjuvant chemotherapy, improved invasive disease-free survival in this patient population (3-year invasive disease-free survival 85.9% v 77.1%; HR 0.58; 99.5% CI 0.41-0.82; P<0.001) [15].
Apr 21PIII OlympiA has met its primary endpoint [14].
Feb 21 In the US, AstraZeneca and Merck & Co have announced the PIII OlympiA trial will move to early primary analysis and reporting following a recommendation from the Independent Data Monitoring Committee (IDMC). Based on the planned interim analysis, the IDMC concluded that the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) and demonstrated a sustainable, clinically relevant treatment effect for olaparib vs placebo for patients with germline BRCA-mutated (gBRCAm) high-risk HER2-negative early breast cancer, and recommend primary analysis now take place. The trial will continue to assess the key secondary endpoints of overall survival and distant disease-free survival [12].
Nov 20PIII OlympiA study is due to complete collection of primary outcome data this month [11].
Dec 19PIII OlympiA study (NCT02032823) has finished recruiting; collection of primary outcome data due to complete Oct 20 [10].
Nov 18PIII OlympiA study (NCT02032823) is still recruiting; collection of primary outcome data due to complete Nov 20 [8].
Dec 16PIII OlympiA study (NCT02032823) is still recruiting; timescales unchanged [5].
Jan 14NCT02032823 (OLYMPIA) is a PIII randomised, double-blind, multi-centre study of olaparib vs placebo as adjuvant treatment in 1320 patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. Patients will receive study treatment for up to a maximum of 12 months. The primary outcome is invasive disease free survival. The study starts Mar 14 and is due to complete Feb 28 (primary outcome data collection 2020) [2].

Evidence based evaluations

LynparzaMetastatic, castration-resistant prostate cancer (mCRPC) - first-line with abiraterone

Information

Lynparza
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Phase III Clinical Trials
Feb 22Has been filed in the EU based on data from PROpel [9].
Nov 21Filings based on PROpel planned for H2 2021 [7].
Sep 19Filings expected 2020+ [3].

Category

A potent inhibitor of human poly (ADP ribose) polymerase enzymes (PARP 1, PARP 2, and PARP 3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo. First-in-class.
Prostate cancer is the second-most common cancer in men, with an estimated 1.6 million new cases diagnosed worldwide in 2015. Approx 10-20% of men with advanced prostate cancer will develop CRPC within 5 years, and at least 84% of these will have metastases at the time of CRPC diagnosis. Of men with no metastases at CRPC diagnosis, 33% are likely to develop metastases within 2 years [1].
Metastatic, castration-resistant prostate cancer (mCRPC) - first-line with abiraterone
Oral

Further information

Yes

Trial or other data

Feb 22AZ announce results from the PROpel PIII trial to be presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium. In a predefined interim analysis, olaparib in combination with abiraterone reduced the risk of disease progression or death by 34% vs abiraterone alone (HR=0.66; 95% CI 0.54-0.81; p<0.0001). Median rPFS was 24.8 months for olaparib plus abiraterone vs 16.6 for abiraterone alone. Results also showed a favourable trend towards improved overall survival (OS) with olaparib plus abiraterone vs abiraterone alone, however the difference did not reach statistical significance at the time of this data cut-off (analysis at 29% data maturity). The trial will continue to assess OS as a key secondary endpoint. Additional data from efficacy endpoints such as time to first subsequent therapy (TFST), second progression-free survival (PFS2), objective response rate (ORR), as well as prostate-specific antigen levels and circulating-tumour-cell counts further support the treatment benefit of olaparib and abiraterone vs abiraterone alone in the overall trial population. The safety and tolerability of olaparib plus abiraterone was in line with that observed in prior clinical trials and the known profiles of the individual medicines. There was no increase in the rate of discontinuation of abiraterone in patients treated with olaparib plus abiraterone, and no detrimental effect on health-related quality of life versus those treated with abiraterone alone (FACT-P questionnaire) [8].
Sep 21PIII PROpel trial meets primary endpoint of improvement in radiographic PFS vs abiraterone monotherapy; OS data are still immature [6].
Jul 20PIII PROpel study is no longer recruiting [5].
Dec 19PIII PROpel study is recruiting [4].
Oct 18PIII PROpel study to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage starts (NCT03732820). 720 men will be recruited from sites including the US, EU & UK. Collection of primary outcome data (progression-free survival) is due to complete Apr 21 [2].

Evidence based evaluations

LynparzaPlatinum-resistant recurrent ovarian cancer - second- and third-line with cediranib

Information

Lynparza
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

A potent inhibitor of human poly (ADP ribose) polymerase enzymes (PARP 1, PARP 2, and PARP 3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo. First-in-class.
Ovarian cancer affects approximately 2.9 in 10,000 people in the EU (equivalent to around 144,000 people) [1].
Platinum-resistant recurrent ovarian cancer - second- and third-line with cediranib
Oral

Further information

Yes

Lynparza Advanced colorectal cancer - first-line maintenance +/- bevacizumab

Information

Lynparza
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

A potent inhibitor of human poly (ADP ribose) polymerase enzymes (PARP 1, PARP 2, and PARP 3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo. First-in-class.
CRC (bowel cancer) is the fourth most common cancer in the UK and the second biggest cancer killer. Nearly 43,000 people are diagnosed with bowel cancer every year in the UK. Around 268,000 people living in the UK today have been diagnosed with bowel cancer. More than nine out of ten new cases (94%) are diagnosed in people over the age of 50, and nearly six out of ten cases (59%) are diagnosed in people aged 70 or over [1].
Advanced colorectal cancer - first-line maintenance +/- bevacizumab
Oral

LynparzaSquamous non-small cell lung cancer (NSCLC) - first-line maintenance therapy with pembrolizumab

Information

Lynparza
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A potent inhibitor of human poly (ADP ribose) polymerase enzymes (PARP 1, PARP 2, and PARP 3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo. First-in-class.
In 2016, around 33,000 people were diagnosed with NSCLC in England. Around 12% had stage IIIA, 8% had stage IIIB and 53% had stage IV disease. The prognosis for people with non-small-cell lung cancer is generally poor. For people with stage III and stage IV disease respectively, around 43% and 16% survive for 1 year or longer [1].
Squamous non-small cell lung cancer (NSCLC) - first-line maintenance therapy with pembrolizumab
Oral

Lynparza Advanced and recurrent endometrial cancer - maintenance with durvalumab following chemotherapy + durvalumab

Information

Lynparza
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

A potent inhibitor of human poly (ADP ribose) polymerase enzymes (PARP 1, PARP 2, and PARP 3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo. First-in-class.
In the UK there are about 8,600 new cases per year [1].
Advanced and recurrent endometrial cancer - maintenance with durvalumab following chemotherapy + durvalumab
Oral

Lynparza Newly diagnosed ovarian cancer - maintenance with bevacizumab and durvalumab following following bevacizumab + chemotherapy + durvalumab

Information

Lynparza
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

A potent inhibitor of human poly (ADP ribose) polymerase enzymes (PARP 1, PARP 2, and PARP 3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo. First-in-class.
Almost 6 in 10 ovarian cancer cases are diagnosed at a late stage in England (2014) and Northern Ireland (2010-2014). Incidence rates for ovarian cancer are projected to rise by 15% in the UK between 2014 and 2035, to 32 cases per 100,000 females by 2035 [1].
Newly diagnosed ovarian cancer - maintenance with bevacizumab and durvalumab following following bevacizumab + chemotherapy + durvalumab
Oral

LynparzaOvarian, fallopian tube or primary peritoneal, relapsed platinum-sensitive BRCA-negative cancer

Information

Lynparza
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
None

Category

A potent inhibitor of human poly (ADP ribose) polymerase enzymes (PARP 1, PARP 2, and PARP 3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo.
There are around 7,400 new ovarian cancer cases in the UK every year. Incidence rates for ovarian cancer in the UK are highest in females aged 75 to 79. Incidence rates are projected to rise by 15% in the UK between 2014 and 2035, to 32 cases per 100,000 females by 2035 [1].
Ovarian, fallopian tube or primary peritoneal, relapsed platinum-sensitive BRCA-negative cancer
Oral

LynparzaRelapsed platinum sensitive, BRCA1/2-positive ovarian cancer - third-line monotherapy

Information

Lynparza
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Jul 21Development discontinued. AstraZenca has removed SOLO-3 from its planned filings. This has no impact on use within the UK since NICE already recommends olaparib for third-line maintenance (within the Cancer Drugs Fund as an option for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose disease has responded to platinum-based chemotherapy only if they have a BRCA1 or BRCA2 mutation and they have had 2 courses of platinum-based chemotherapy) [14].

Category

A potent inhibitor of human poly (ADP ribose) polymerase enzymes (PARP 1, PARP 2, and PARP 3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo. First-in-class.
Ovarian cancer affects approximately 2.9 in 10,000 people in the EU (equivalent to around 144,000 people). Mutations in BRCA1 and BRCA2 account for around 15 percent of ovarian cancers overall [1].
Relapsed platinum sensitive, BRCA1/2-positive ovarian cancer - third-line monotherapy
Oral

Evidence based evaluations