Last updated: 09/23/20

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European Medicines Agency
Herceptin is indicated for the treatment of patients with HER2-positive metastatic breast cancer...
HER-2 positive | HER2 Positive Breast Cancer | trastuzumab
Evidence: A2 - Guideline -> A1 - Approval
3 days ago
IPATential150: Phase III study of ipatasertib (ipat) plus abiraterone (abi) vs placebo (pbo) plus abi in metastatic castration-resistant prostate cancer (mCRPC)(ESMO 2020)
...In PTEN loss by IHC pts, median rPFS was 18.5 mo (95% CI: 16.3, 22.1) with ipat and 16.5 mo (95% CI: 13.9, 17.0) with pbo (HR: 0.77; 95% CI: 0.61, 0.98; P = 0.0335)....In this primary endpoint analysis, ipat + abi as first-line treatment for mCRPC resulted in significantly improved rPFS and antitumor activity vs pbo + abi in pts with PTEN-loss mCRPC, but not in the ITT.
PTEN loss | Prostate Cancer | GDC-0068 + DST-2970 + prednisolone
Evidence: B - Late Trials
5 days ago
LBA12 - PALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer(ESMO 2020)
...iDFS was similar between the two arms, with 3-year iDFS of 88.2% for P and ET, and 88.5% for ET alone (HR 0.93, 95% confidence interval 0.76-1.15), crossing a pre-specified futility boundary. No benefit from P was observed within clinicopathologic subgroups....Within the PALLAS trial, at IA2, two years of adjuvant palbociclib with ET did not improve iDFS compared to ET alone.
HR positive | HER2 Negative Breast Cancer | palbociclib
Evidence: C3 – Early Trials -> B - Late Trials
5 days ago
LBA18 - Overall survival (os) results from SOLAR-1, a phase III study of alpelisib (ALP) + fulvestrant (FUL) for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC)(ESMO 2020)
With mOS follow-up of 30.8 mo, mOS was 39.3 mo (95% CI 34.1-44.9) with ALP + FUL and 31.4 mo (95% CI 26.8-41.3) with PBO + FUL (HR 0.86; 95% CI 0.64-1.15; P=0.15); OS did not cross the prespecified boundary….Though not statistically significant, OS was prolonged by a clinically relevant ≈8 mo with ALP when added to FUL in...PIK3CA-mut ABC.
PIK3CA mutation | HER2 Negative Breast Cancer | fulvestrant + alpelisib
Evidence: C3 – Early Trials -> B - Late Trials
5 days ago
LBA6_PR - Nivolumab (nivo) plus chemotherapy (chemo) versus chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma (EAC): First results of the CheckMate 649 study(ESMO 2020)
Adults with previously untreated, unresectable advanced, or metastatic GC/GEJC/EAC were enrolled...With a minimum follow-up of 12 months (mo), NIVO + chemo showed a statistically significant improvement in OS and PFS vs chemo in pts whose tumors expressed PD-L1 CPS ≥ 5 (OS, HR 0.71 [98.4% CI 0.59–0.86; P < 0.0001] and PFS, HR 0.68 [98% CI 0.56–0.81; P < 0.0001]).
PD-L1 expression | Gastric Cancer | nivolumab
Evidence: B - Late Trials
5 days ago
LBA6_PR - Nivolumab (nivo) plus chemotherapy (chemo) versus chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma (EAC): First results of the CheckMate 649 study(ESMO 2020)
Adults with previously untreated, unresectable advanced, or metastatic GC/GEJC/EAC were enrolled...With a minimum follow-up of 12 months (mo), NIVO + chemo showed a statistically significant improvement in OS and PFS vs chemo in pts whose tumors expressed PD-L1 CPS ≥ 5 (OS, HR 0.71 [98.4% CI 0.59–0.86; P < 0.0001] and PFS, HR 0.68 [98% CI 0.56–0.81; P < 0.0001]).
PD-L1 expression | Gastroesophageal Junction Adenocarcinoma | nivolumab
Evidence: B - Late Trials
5 days ago
Foundation Medicine and Takeda Announce Collaboration To Develop FoundationOne CDx and FoundationOneLiquid CDx as Companion Diagnostics for Takeda’s Late-Stage Lung Cancer Portfolio(Businesswire)
“Foundation Medicine, Inc. and Takeda Pharmaceuticals USA, Inc…announced a collaboration for the development of Foundation Medicine’s tissue- and blood-based companion diagnostics for use with marketed and investigational treatments in Takeda’s late-stage lung cancer portfolio. If approved, the appropriate companion diagnostics would be used to identify patients who may be eligible for mobocertinib, an investigational drug being evaluated for the treatment of patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC), and ALUNBRIG® (brigatinib), Takeda’s tyrosine kinase inhibitor (TKI) recently FDA-approved to treat patients with TKI-naïve anaplastic lymphoma kinase-positive (ALK+) mNSCLC.”
Non Small Cell Lung Cancer + Solid Tumor + Lung Cancer | brigatinib + TAK-788
FoundationOne® CDx / Roche; FoundationOne® Heme CDx / Roche
Licensing / partnership
6 days ago
1424MO - Perioperative FLOT plus ramucirumab versus FLOT alone for resectable esophagogastric adenocarcinoma– Updated results and subgroup analyses of the randomized phase II/III trial RAMSES/FLOT7 of the German AIO and Italian GOIM(ESMO 2020)
This is a prospective, international, randomized, investigator-initiated phase II/III trial. Patients (pts) with resectable, Her2-negative EGA(≥ cT2 or cN+) were randomized to 4 pre-and post-operative cycles of FLOT (docetaxel 50 mg/m2; oxaliplatin 85 mg/m2; leucovorin 200 mg/m2; 5-FU 2600 mg/m2, q2w) alone (Arm A) or FLOT with RAM 8mg/kg q2w, followed by 16 cycles RAM (Arm B, FLOT-RAM). Here, we report the main results along with the subgroup analysis explaining the higher rate of R0-resection in the FLOT-RAM arm...In total, 180 pts (FLOT, 91; FLOT-RAM, 89) were randomized. Baseline characteristics were similar between arms (male, 73%; median age, 60y; cT3/T4, 83%; cN+, 78%; GEJ, 54%). The rate of signet-ring cell cancer was high (40%). As reported at ASCO, no difference in path response rates was seen (FLOT, 30%; FLOT-RAM, 27%). However, FLOT-RAM significantly improved R0-resection rate (FLOT, 82%; FLOT-RAM, 96%, p=0.0078). This difference was due to less pts in the FLOT-RAM arm with disease progression prior to operation (FLOT, 6%; FLOT-RAM, 1%), more pts proceeding to operation (FLOT, 93%; FLOT-RAM, 97%), more pts receiving resectional surgery (FLOT, 88%; FLOT-RAM, 97%), and less pts having residual tumor out of the resected pts (FLOT, 4; FLOT-RAM, 1).
HER-2 negative | Gastroesophageal Junction Adenocarcinoma | ramucirumab
Evidence: B - Late Trials
6 days ago
1423MO - End-of-study analysis from JACOB: A phase III study of pertuzumab (P) + trastuzumab (H) and chemotherapy (CT) in HER2-positive metastatic gastric or gastro-esophageal junction cancer (mGC/GEJC)(ESMO 2020)
CONTRADICTING EVIDENCE: In JACOB (NCT01774786), a double-blind, placebo-controlled, randomised, multicentre, phase III study in patients (pts) with HER2-positive mGC/GEJC, addition of P to H + CT did not significantly improve overall survival (OS) v placebo (PLA) at >24.4 months (m) median follow-up; median OS: 17.5 m with P + H + CT v 14.2 m with PLA + H + CT, HR 0.84 (95% CI 0.71, 1.00); p=0.057.
HER-2 positive | Gastroesophageal Junction Adenocarcinoma | trastuzumab + pertuzumab
Evidence: B - Late Trials
6 days ago
Tiziana Life Sciences announces planned spin out of StemPrintER into a new publicly listed company, AccuStem Sciences(Tiziana Life Sciences Press Release)
"Tiziana Life Sciences plc…today announced plans for demerging its StemPrintER asset into a separate and independently listed public company, Accustem Sciences Limited…The Company will hold a shareholders meeting on October 2, 2020 to vote on the planned demerger. As part of the demerger, Tiziana will provide the new entity with $1.3M in cash...To effect the demerger, Tiziana plans to distribute a 1:1 share dividend to its shareholders with a record date of 0700 London time on October 30, 2020. Accustem Sciences will begin the process of seeking CE Mark approval in November of 2020 with anticipated commercialization in Europe in the second quarter of 2021. Subsequently, the Company also intends to seek FDA approval."
StemPrintER™ / Tiziana Life Sci
Licensing / partnership
6 days ago
Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer(Roche Press Release)
"Roche...today announced U.S. Food and Drug Administration (FDA) approval for the expanded use of CINtec® PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV)...Laboratories can now use CINtec PLUS Cytology to triage positive results from the cobas® HPV Test run on the fully integrated, automated and high-throughput cobas® 6800/8800 Systems...The World Health Organization has set goals for countries to take action to eliminate cervical cancer by 2030."
Solid Tumor + Cervical Cancer
CINtec® PLUS Cytology / Roche
FDA event
8 days ago
1281P - The prognostic impact of tissue tumour mutational burden (TMB) in the first-line treatment of advanced non-oncogene addicted non-small cell lung cancer (NSCLC): A systematic review and meta-analysis of randomized controlled trials(ESMO 2020)
Indirect comparisons for efficacy outcomes showed that ICIs were associated with a statistically significant advantage over CT alone in terms of response rate (RR 1.37, 95% CI 0.94 - 1.99), progression-free survival (PFS; HR 0.57, 95% CI 0.48 - 0.67) and OS (HR 0.72, 95% CI 0.60 - 0.86), supporting the use of I-O regimens strategy within the TMB-high subgroup (1255 patients)....Although more prospective data are warranted, we inferred that monitoring TMB, in addition to the existing PD-L1 expression level, could represent the preferable option for the first-line management of advanced non-oncogene addicted NSCLC.
TMB-H | Non Small Cell Lung Cancer
Evidence: C3 – Early Trials -> B - Late Trials
10 days ago
Bio-Techne and Hall of Famer Cal Ripken Jr -announce partnership to raise awareness and education to empower men with prostate cancer(Bio-Techne Press Release)
"Bio-Techne Corporation…today announced that Exosome Diagnostics…has established a new partnership with Hall of Famer and baseball's all-time ‘Iron Man’, Cal Ripken Jr...Today Ripken, 60, is leading a national effort with Exosome Diagnostics to build education and awareness of the ExoDx ™ Prostate test, encourage men to proactively take action and be aware of their prostate health. The ExoDx™ Prostate (EPI) test played an important role in the management of Cal's prostate cancer."
ExoDx™ Prostate (IntelliScore) Test / Bio-Techne
Licensing / partnership
10 days ago
Natera's Signatera™ MRD test receives a final coverage decision from Noridian in colorectal cancer(Natera Press Release)
"Natera, Inc…today announced that Noridian, the Medicare Administrative Contractor (MAC) for Northern California, has finalized a final local coverage article (LCA) to provide Medicare benefits for serial use of the Signatera molecular residual disease (MRD) test in patients with a history of colorectal cancer."
Signatera™ / Natera
Reimbursement
10 days ago
Immunoscore to select patients in the POCHI trial, a phase II multicenter trial testing immunotherapy with chemotherapy and bevacizumab in metastatic colorectal cancer(GlobeNewswire)
"HalioDx SAS…announced that it has entered into a Collaboration Agreement with the FFCD, the French Cooperative Group dedicated exclusively to digestive oncology, on the Phase II multicenter POCHI trial (FFCD1703 - NCT04262687) in which immune response at the tumor site will be used to inform patient eligibility to participiate in the POCHI trial. The objective of the trial is to evaluate the efficacy of pembrolizumab in combnation with XELOX (capecitabine plus oxaliplatin) and bevacizumab as first line treatment of microsatellite stable (MSS) / proficient mismatch repair system (pMMR) metastatic colorectal cancer (mCRC) with high immune infiltrate....MSS/pMMR tumors presenting a high immune infiltrate as assessed by Immunoscore® could be sensitive to ICI therapy."
Colorectal Cancer + Solid Tumor + Gastrointestinal Cancer | pembrolizumab + bevacizumab + oxaliplatin + capecitabine
Immunoscore® / HalioDx
Trial status | Licensing / partnership
14 days ago
Zai Lab Announces NMPA Approval of ZEJULA® (Niraparib) for First-Line Maintenance Treatment of Ovarian Cancer in China(Zai Lab Press Release)
...Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, today announced that the China National Medical Products Administration (NMPA) has approved its supplemental New Drug Application (sNDA) for ZEJULA® (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
Ovarian Cancer | niraparib
Evidence: A1 - Approval
14 days ago
FDA Approves First NGS-Based Companion Diagnostic for RET Fusion-Positive Non-Small Cell Lung Cancer(PRNewswire)
"The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify RET fusion-positive, metastatic non-small cell lung cancer (NSCLC) patients who are candidates for GAVRETO™ (pralsetinib), a targeted therapy developed by Blueprint Medicines….It is now also the first and only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC. Thermo Fisher will update the Oncomine Dx Target Test to enable it to report RET fusions in the U.S. before the end of the year."
Non Small Cell Lung Cancer + Solid Tumor + Lung Cancer | pralsetinib
Oncomine™ Dx Target Test / Thermo Fisher Scientific
FDA event
16 days ago
Janssen Announces European Commission Decision for Expanded Use of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukaemia (CLL)(Businesswire)
...The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved a variation to the marketing authorisation for IMBRUVICA® (ibrutinib), extending the approved indication in chronic lymphocytic leukaemia (CLL) to include combination with rituximab for previously untreated adult patients.
Chronic Lymphocytic Leukemia | rituximab + ibrutinib
Evidence: A1 - Approval
17 days ago
Oncocyte and the Guardian Research Network® announce strategic alliance(Oncocyte Press Release)
"Oncocyte Corporation...and the Guardian Research Network® (GRN)...today announced a strategic collaboration to create a comprehensive solution for pharma clients from patient recruitment to regulatory approvals. Oncocyte and GRN aim to leverage their joint capabilities by bringing together GRN’s clinical trial enrollment and data science technology with Oncocyte’s proprietary molecular tests, including DetermaRx™ for early stage lung cancer and DetermaIO™ for immunotherapy selection, as well as Oncocyte’s pharma and companion diagnostic development services. The collaboration is designed to reduce the time to populate immune targeting trials while also improving chances for successful trials through proprietary molecular patient stratification."
DetermaIO™ / Oncocyte; DetermaRx™ / Oncocyte
Licensing / partnership
20 days ago
Genentech Announces FDA Approval of Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer(Roche Press Release)
FDA also granted Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer
RET fusion | Thyroid Cancer | pralsetinib
Evidence: C3 – Early Trials -> B - Late Trials
20 days ago
Genentech Announces FDA Approval of Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer(Roche Press Release)
FDA also granted Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer
RET mutation | Medullary Thyroid Cancer | pralsetinib
Evidence: C3 – Early Trials -> B - Late Trials
20 days ago
FDA
GAVRETO is a kinase inhibitor indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion- positive nonsmall cell lung cancer (NSCLC) as detected by an FDA approved test.
RET fusion | Non Small Cell Lung Cancer | pralsetinib
Evidence: B - Late Trials -> A1 - Approval
20 days ago
Natera receives final medicare coverage for its Signatera™ MRD test in stage II-III colorectal cancer(Natera Press Release)
"Natera, Inc…today announced that the CMS Molecular Diagnostics Program (MOLDX) has finalized a local coverage determination (LCD) to provide Medicare benefits for serial use of the Signatera molecular residual disease (MRD) test in patients with stage II or III colorectal cancer (CRC)....'Colorectal cancer remains one of the deadliest forms of cancer, but it's also relatively unique as a disease where early detection of relapse is known to improve outcomes,' said Scott Kopetz, MD, PhD..."
Signatera™ / Natera
Reimbursement | Media quote
20 days ago
Biocartis expands collaboration with LifeArc(Biocartis Press Release)
"Biocartis Group NV…today announces the expansion of its collaboration with LifeArc, a UK based independent medical research charity, with a new agreement aimed at the development of highly innovative prototype assays…The new license and development agreement is an extension of the existing partnership between LifeArc and Biocartis, which is today focused on the development and the commercialization of the Idylla™ ABC (Advanced Breast Cancer) assay. This assay is positioned to target a multi-gene panel of predictive and resistance-inducing mutations based on an FFPE3 sample type." "
Idylla™ ABC (Advanced Breast Cancer) Assay / Biocartis
Licensing / partnership
21 days ago
Vela Diagnostics launches NGS-based, pan-cancer assay that detects SNVs, INDELS, CNVs, MSI, fusions and oncogenic pathogens in more than 60 genes()
"Vela Diagnostics announced today the launch of the OncoKey™ SL 60 Plus Assay. The assay is a next-generation sequencing (NGS)-based, pan-cancer test that detects single nucleotide variations (SNVs), insertions/deletions (INDELs), copy number variations (CNVs), microsatellite instability (MSI), fusions and oncogenic pathogens in more than 60 targeted genes, in formalin-fixed paraffin-embedded (FFPE) tissue specimens...The OncoKey™ SL 60 Plus Assay is the first product in Vela Diagnostics’ OncoKey™ SL portfolio that provides flexible automated NGS solutions for oncology to laboratories."
OncoKey™ SL 60 Plus Assay / Luye Group
Launch
22 days ago
FDA
ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
Acute Myelogenous Leukemia | azacitidine oral
Evidence: B - Late Trials -> A1 - Approval
23 days ago
Imfinzi approved in the EU for the treatment of extensive-stage small cell lung cancer(AstraZeneca Press Release)
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.
Small Cell Lung Cancer | durvalumab
Evidence: A1 - Approval
23 days ago
Natera announces collaboration with Massachusetts General Hospital for a prospective randomized clinical trial in early stage breast cancer(Natera Press Release)
"Natera, Inc…today announced a collaborative agreement with Mass General Cancer Center (MGCC) of Massachusetts General Hospital, related to an investigator-initiated multi-center, Phase II randomized clinical trial of Ribociclib (Kisqali®)…for the treatment of ER-positive breast cancer (LEADER), the first circulating tumor DNA (ctDNA)-based study of a CDK4/6 inhibitor in ER-positive early stage breast cancer…Natera's Signatera test will be used to determine patient enrollment eligibility based on presence of ctDNA via longitudinal monitoring and to evaluate response based on ctDNA clearance as the primary endpoint."
ribociclib
Signatera™ / Natera
Licensing / partnership
27 days ago
AmoyDx collaborates with Haihe Pharmaceutical to co-develop companion diagnostics for Japan market(AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd…announced that it signed an agreement with Haihe Pharmaceutical to develop a Companion Diagnostic (CDx) test supporting the novel MET inhibitor Glumetinib (SCC244)….Under the terms of the agreement, AmoyDx will develop and register the AmoyDx® Pan Lung Cancer PCR Panel (9-in-1 Plus) in Japan, to get the PMDA approval for an intended use as a c-MET exon14 skipping companion diagnostic for Haihe's Glumetinib (SCC244), a novel MET kinase inhibitor targeting c-MET exon14 skipping, in subjects with Non-Small Cell Lung Cancer."
SCC244
AmoyDx® Pan Lung Cancer PCR Panel / Amoy Diagnostics
Licensing / partnership
28 days ago
FDA approves Foundation Medicine’s FoundationOne®Liquid CDx, a comprehensive pan-tumor liquid biopsy test with multiple companion diagnostic indications for patients with advanced cancer(Foundation Medicine Press Release)
"Foundation Medicine, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne®Liquid CDx, the Company’s comprehensive pan-tumor liquid biopsy test. FoundationOne Liquid CDx will be commercially available on Friday, August 28 and is covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries in accordance with the Centers for Medicare and Medicaid Services National Coverage Decision Memo criteria."
FoundationOne® Liquid CDx / Roche
FDA event
28 days ago
Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial(Lancet Oncol)
...patients were assigned to receive veliparib plus carboplatin-paclitaxel (veliparib group) and 172 were assigned to receive placebo plus carboplatin-paclitaxel (control group). Median follow-up at data cutoff (April 5, 2019) was 35·7 months (IQR 24·9-43·6) in the veliparib group and 35·5 months (23·1-45·9) in the control group....resulted in significant and durable improvement in progression-free survival in patients with germline BRCA mutation-associated advanced breast cancer.
BRCA2 mutation | HER2 Negative Breast Cancer | ABT-888
Evidence: B - Late Trials
28 days ago
Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial(Lancet Oncol)
...patients were assigned to receive veliparib plus carboplatin-paclitaxel (veliparib group) and 172 were assigned to receive placebo plus carboplatin-paclitaxel (control group). Median follow-up at data cutoff (April 5, 2019) was 35·7 months (IQR 24·9-43·6) in the veliparib group and 35·5 months (23·1-45·9) in the control group....resulted in significant and durable improvement in progression-free survival in patients with germline BRCA mutation-associated advanced breast cancer.
BRCA1 mutation | HER2 Negative Breast Cancer | ABT-888
Evidence: B - Late Trials
28 days ago
Natera’s Signatera™ test receives CE mark(Natera Press Release)
"Natera, Inc...today announced that it has received the CE mark for the Signatera test...With the CE mark, Natera can now make Signatera available to clinics and hospital systems throughout Europe to support patient management and clinical research."
Signatera™ / Natera
European regulatory
28 days ago
FDA Approves FoundationOne Liquid CDx To Serve As Rubraca (Rucaparib) Companion Diagnostic To Identify Eligible Patients With BRCA1/2-Mutant, Metastatic Castration-Resistant Prostate Cancer (MCRPC)(Clovis Oncology Press Release)
"Clovis Oncology...announced today that the...FDA approved the FoundationOne® Liquid CDx, Foundation Medicine’s comprehensive liquid biopsy test for all solid tumors with multiple companion diagnostic indications, including for Rubraca ® (rucaparib) tablets, recently approved for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy."
Prostate Cancer + Urothelial Cancer + Solid Tumor + Genito-urinary Cancer | rucaparib
FoundationOne® Liquid CDx / Roche
FDA event
28 days ago