API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
Keytruda (pembrolizumab) is an anti-programmed death receptor-1 (PD-1) therapy, which is being evaluated in combination with Lynparza (olaparib), a PARP inhibitor for the treatment of metastatic nonsquamous non-small cell lung cancer.
Lead Product(s): Pembrolizumab,Olaparib,Pemetrexed
Therapeutic Area: Oncology Product Name: Keytruda
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2024
Details:
Imfinzi (durvalumab), a PD-L1 inhibitor plus platinum-based chemotherapy followed by Imfinzi plus Lynparza (olaparib), a PARP inhibitor, demonstrated an improvement in patients with mismatch repair proficient advanced endometrial cancer compared to chemotherapy alone.
Lead Product(s): Durvalumab,Olaparib
Therapeutic Area: Oncology Product Name: Imfinzi
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2024
Details:
Ibyra (olaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor, which is approved in India for the treatment of HRD-positive and BRACA-positive cancer patients.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Ibyra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 13, 2024
Details:
TNG348 is a novel selective inhibitor of USP1 (ubiquitin-specific protease 1) which is in phase 1/2 clinical trials as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant or other HRD+ (homologous recombination deficient) cancers.
Lead Product(s): TNG348,Olaparib
Therapeutic Area: Oncology Product Name: TNG348
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2024
Details:
Merck is assessing its leading product, Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, in Phase III clinical trials for treating patients with metastatic squamous non-small cell lung cancer.
Lead Product(s): Pembrolizumab,Olaparib
Therapeutic Area: Oncology Product Name: Keytruda
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2023
Details:
Imfinzi (durvalumab) a PD-L1 inhibitor in combination with Lynparza (olaparib) is a first-in-class PARP inhibitor is being evaluated in phase 3 clinical trials for the treatment of advanced or recurrent endometrial cancer.
Lead Product(s): Durvalumab,Olaparib
Therapeutic Area: Oncology Product Name: Imfinzi
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2023
Details:
TNG348, a novel inhibitor of USP1 (ubiquitin-specific protease 1), is being developed for the treatment of BRCA1/2 mutant and other HRD+ (homologous recombination deficient) cancers.
Lead Product(s): TNG348,Olaparib
Therapeutic Area: Oncology Product Name: TNG348
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2023
Details:
Lynparza (olaparib) is a first-in-class PARP inhibitor and approved in combination with abiraterone for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2023
Details:
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment which leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2023
Details:
Lynparza (olaparib), a first-in-class PARP inhibitor, gets FDA approval for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer. It is already approved in the US for HRR gene-mutated mCRPC.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2023
Details:
Imfinzi (durvalumab) is a human mAb that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.
Lead Product(s): Durvalumab,Olaparib
Therapeutic Area: Oncology Product Name: Imfinzi
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2023
Details:
Lynparza® (olaparib), PARP inhibitor, in combination with abiraterone (an androgen biosynthesis inhibitor) and prednisone or prednisolone is being investigated in BRCA-mutated metastatic castration-resistant prostate cancer.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2023
Details:
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment which leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.
Lead Product(s): Olaparib,Durvalumab
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2023
Details:
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment which leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2023
Details:
LP-100 in combination with PARP inhibitors preferentially damages DNA in cancer cells lacking nucleotide excision repair capabilities. Sensitivity to LP-100 is also higher in tumors with HRR deficiency, which involved in the repair of DNA damage from LP-100.
Lead Product(s): Irofulven,Olaparib
Therapeutic Area: Oncology Product Name: LP-100
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2023
Details:
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment which leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2023
Details:
LYNPARZA (olaparib) in combination with abiraterone and prednisone or prednisolone reduced the risk of disease progression or death by 34% (HR=0.66 [95% CI, 0.54-0.81]; p<0.0001) versus placebo plus abiraterone and prednisone or prednisolone, based on investigator assessment.
Lead Product(s): Olaparib,Abiraterone Acetate
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2022
Details:
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in HRR, such as those with mutations in BRCA1 and/or BRCA2, or those where deficiency is induced by other agents.
Lead Product(s): Olaparib,Abiraterone Acetate
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: MSD Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2022
Details:
Patients in the first regimen will be dosed with NUV-868 in combination with olaparib for the treatment of ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors.
Lead Product(s): NUV-868,Olaparib
Therapeutic Area: Oncology Product Name: NUV-868
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
LYNPARZA (olaparib), is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells.
Lead Product(s): Olaparib,Abiraterone Acetate
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: MSD Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2022
Details:
GFH009 was tested against NCI-H209 SCL xenografts in athymic nude mice in four treatment groups of eight mice each (n=32) consisting of GFH009 alone, olaparib (a PARP inhibitor) alone, a combined regimen of GFH009 and olaparib, and a vehicle control.
Lead Product(s): GFH009,Olaparib
Therapeutic Area: Oncology Product Name: GFH009
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2022
Details:
Lynparza (olaparib) is first-in-class PARP inhibitor and first targeted treatment to block DNA damage response in cells/tumours harboring deficiency in HRR.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: MSD Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
LYNPARZA (Olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
The primary results from the PAOLA-1 trial showed that LYNPARZA (olaparib) plus bevacizumab reduced the risk of disease progression or death by 67% (HR=0.33 [95% CI, 0.25-0.45]).
Lead Product(s): Olaparib,Bevacizumab
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2022
Details:
The approval by CNMPA was based on HRD-positive subgroup exploratory analysis of PAOLA-1 Phase III trial which showed Lynparza (olaparib) plus bevacizumab demonstrated a substantial PFS improvement versus bevacizumab for patients with HRD-positive advanced ovarian cancer.
Lead Product(s): Olaparib,Bevacizumab
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: MSD Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2022
Details:
Landmark 5-year follow-up of PAOLA-1 Phase III trial demonstrated Lynparza (olaparib) plus bevacizumab meaningfully extended survival with 65.5% of HRD-positive patients surviving 5 years vs. 48.4% treated with bevacizumab and placebo.
Lead Product(s): Olaparib,Bevacizumab
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2022
Details:
Landmark 5-year follow-up of PAOLA-1 Phase III trial demonstrated Lynparza (olaparib) plus bevacizumab meaningfully extended survival with 65.5% of HRD-positive patients surviving 5 years vs. 48.4% treated with bevacizumab and placebo.
Lead Product(s): Olaparib,Bevacizumab
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: MSD Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2022
Details:
Inhibition of PARP proteins with Lynparza (olaparib) leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: MSD Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2022
Details:
Lynparza (olaparib) is the first PARP inhibitor to demonstrate a significant improvement in radiographic progression-free survival in combination with abiraterone versus abiraterone alone in 1st-line mCRPC irrespective of biomarker status.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2022
Details:
The safety and tolerability of LYNPARZA (olaparib) in combination with abiraterone and prednisone or prednisolone was in line with that observed in prior clinical trials and the known proles of the individual medicines.
Lead Product(s): Olaparib,Abiraterone Acetate
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 16, 2022
Details:
LYNPARZA (olaparib), is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 04, 2022
Details:
In trial, LYNPARZA (olaparib) demonstrated a statistically significant and clinically meaningful improvement in primary endpoint of invasive disease-free survival, reducing risk of invasive breast cancer recurrences, second cancers or death by 42% versus placebo.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2022
Details:
Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% versus placebo.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2022
Details:
Results showed that LYNPARZA (olaparib) in combination with abiraterone plus prednisone signicantly improved radiographic progression-free survival v/s abiraterone plus prednisone, as rest-line treatment for patients with metastatic castration-resistant prostate cancer.
Lead Product(s): Olaparib,Abiraterone Acetate
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2022
Details:
Humalutin® (177Lu-DOTA-NNV003), acts by inducing potentially cytotoxic DNA breaks in the NHL cells, sensitising these cells to olaparib, which prevents repair of DNA breaks by blocking activity of DNA repair enzymes poly (ADP ribose) polymerase 1 and 2 (PARP1 and PARP2).
Lead Product(s): 177Lu-DOTA-NNV003,Olaparib
Therapeutic Area: Oncology Product Name: Humalutin
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2022
Details:
CERo’s technology aims to expand the therapeutic potential of CER T cell engineered-based therapies by introducing distinct and complementary tumor cell clearance pathways into a single T cell.
Lead Product(s): CER T-cell Therapy,Olaparib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2022
Details:
CDK12 inhibitor demonstrates strong anti-tumor activity as single agent and in combination with a DNA damaging agent and a PARP inhibitor in models of breast, lung, and ovarian cancer.
Lead Product(s): SY-5609,Olaparib,Lurbinectedin
Therapeutic Area: Oncology Product Name: SY-5609
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2022
Details:
Data showed that combining PCM-075 (onvansertib) with olaparib led to a statistically significant survival benefit compared to treatment with either agent alone in each of the three evaluated PDX models. Results showed combination was well tolerated.
Lead Product(s): Onvansertib,Olaparib
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2022
Details:
Positive results from OlympiA Phase III trial showed Lynparza (olaparib) demonstrated statistically significant and clinically meaningful improvement in overall survival versus placebo in adjuvant treatment of patients with germline BRCA-mutated HER2 negative breast cancer.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck Group
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
Positive results from OlympiA Phase III trial showed Lynparza (olaparib) demonstrated a statistically significant and clinically meaningful improvement in overall survival versus placebo in adjuvant treatment of patients with germline BRCA-mutated HER2-negative breast cancer.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
In OlympiA trial, LYNPARZA (olaparib), demonstrated a statistically significant improvement in overall survival (OS) versus placebo for the adjuvant treatment of patients with early breast cancer.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
Merck is discontinuing the study for Phase 3 KEYLYNK-010 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with LYNPARZA, a PARP inhibitor, as it did not demonstrate a benefit in overall survival at the interim analysis.
Lead Product(s): Pembrolizumab,Olaparib
Therapeutic Area: Oncology Product Name: Keytruda
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2022
Details:
LYNPARZA (olaparib) demonstrated statistically significant and clinically meaningful improvement in invasive disease-free survival, reducing risk of breast cancer recurrences, or death, by 42% versus placebo based on a hazard ratio of 0.58; 95% confidence interval.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2022
Details:
The approval was based on thr Updated results from the OlympiA trial showed LYNPARZA reduced the risk of death by 32% versus placebo, a statistically significant improvement in OS, a key secondary endpoint.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2022
Details:
The safety and tolerability of Lynparza in combination with abiraterone was in line with that observed in prior clinical trials and the known profiles of the individual medicines.
Lead Product(s): Olaparib,Abiraterone Acetate
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2022
Details:
Positive results from Phase 3 PROpel trial showed LYNPARZA in combination with abiraterone plus prednisone demonstrated a statistically significant and clinically meaningful improvement in rPFS, versus abiraterone plus prednisone for treatment of patients with mCRPC.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisolone
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2022
Details:
First patient has been enrolled in the DOVACC Phase II clinical trial assessing the impact of the Company’s telomerase vaccine, UV1, a peptide-based vaccine inducing a specific T cell response.
Lead Product(s): UV1,Olaparib,Durvalumab
Therapeutic Area: Oncology Product Name: UV1
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2021
Details:
Lynparza is a targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD continue to research Lynparza in early and metastatic breast cancer patients with a BRCA mutation.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2021
Details:
The results showed LYNPARZA demonstrated a statistically signicant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrence, second cancers or death by 42% versus placebo.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck Group
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2021
Details:
RP-3500, a potential leading ATR inhibitor demonstrated a manageable safety profile and promising early antitumor efficacy in patients with tumors, and alone or in combination with talazoparib, a PARP inhibitor, in patients with advanced solid tumors.
Lead Product(s): Niraparib Tosylate,Olaparib
Therapeutic Area: Oncology Product Name: RP-3500
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2021