Talazoparib

European Commission Approves Pfizer’s TALZENNA® in Combination with XTANDI® for Adult Patients with Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Monday, January 8, 2024
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, European Commission, Food, HRR, Risk, Movement, Prognosis, PFE, Confidence interval, Disease, Prostate cancer, Doctor of Philosophy, Civil service commission, Cancer, University, PARP, Death, Clinical Cancer Research, University of Glasgow, ADP, Talazoparib, Patient, Safety, Medicine, Inc., Pharmaceutical industry

Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
  • With this approval, TALZENNA is now the first and only PARP inhibitor licensed in the European Union for use with XTANDI for patients with mCRPC, with or without gene mutations.
  • “The European Commission’s approval of talazoparib in combination with enzalutamide offers a meaningful advancement for the treatment of patients with metastatic castration-resistant prostate cancer, the most advanced and aggressive stage of the disease.”
    “After years of fighting prostate cancer, it can be devastating for a patient to learn that their cancer has stopped responding to testosterone-lowering treatments.
  • At this stage of the disease, the prognosis is generally poor,” said Erik Briers, MS, PhD, Vice Chairman, Europa UOMO, a European advocacy movement for people with prostate cancer.

Exelixis Announces Appointment of Amy Peterson, M.D., as Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer

Retrieved on: 
Wednesday, August 23, 2023
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Talazoparib, Medical Affairs Bureau, Drug development, University, Internal medicine, Prostate cancer, Culture, IO, BeiGene, Thomas Jefferson University, Cancer, Investigational New Drug, Patient, FDA, Exelixis, Medivation, Northwestern Memorial Hospital, Breast cancer, EXEL, Pharmaceutical industry, Genentech

Exelixis, Inc. (Nasdaq: EXEL) today announced it has appointed Amy Peterson, M.D., its next Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer.

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced it has appointed Amy Peterson, M.D., its next Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer.
  • She joins Exelixis as the company accelerates development of its product pipeline and builds on the success of its global cabozantinib oncology franchise.
  • Most recently, Dr. Peterson was at CytomX, first as Executive Vice President and Chief Development Officer and then as President and Chief Operating Officer.
  • “It’s a pleasure to welcome Dr. Amy Peterson to Exelixis as the company’s next Chief Medical Officer.

Royalty Pharma Reports Second Quarter 2023 Results

Retrieved on: 
Tuesday, August 8, 2023
Acceleration, Net, Pressure, University, Civil service commission, Astellas Pharma, Chronic lymphocytic leukemia, Vertex, Calendar, Aplastic anemia, DPP, GAAP, Leuprorelin, Sale, Ulcerative colitis, Psoriasis, Gilead, EBITDA, Acquisition, European Commission, Patient, Risk, Metastasis, Cystic fibrosis, Growth, Johnson & Johnson, California Miramar University, FDA, Sacituzumab govitecan, Regulation of tobacco by the U.S. Food and Drug Administration, Death, Food, Ivacaftor, Pfizer, Talazoparib, Bank, Video game, Music, Vaccine, Pharmaceutical industry, Real estate, Cryptocurrency, Berotralstat, Apalutamide, Nusinersen, Elexacaftor/tezacaftor/ivacaftor, Adjustment, Guselkumab, Ibrutinib

Drivers of total royalty receipts in the second quarter of 2023 are discussed below, based on commentary from the marketers of the products underlying the royalties in the preceding quarter (as royalty receipts generally lag product performance by one calendar quarter).

Key Points: 
  • Drivers of total royalty receipts in the second quarter of 2023 are discussed below, based on commentary from the marketers of the products underlying the royalties in the preceding quarter (as royalty receipts generally lag product performance by one calendar quarter).
  • Royalty Pharma acquired a royalty interest in Trelegy in July 2022 and began receiving royalty receipts in the third quarter of 2022.
  • During the second quarter of 2023, Royalty Pharma began repurchasing its Class A ordinary shares and repurchased approximately four million shares for $134 million.
  • The weighted-average diluted Class A ordinary shares outstanding for the second quarter of 2023 was 606 million as compared to 607 million for the first quarter of 2023.

Repare Therapeutics Announces Publication in Nature Medicine Highlighting Clinical Benefit of Camonsertib in Advanced Solid Tumors

Retrieved on: 
Tuesday, June 6, 2023
Science, Other Science, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Talazoparib, DNA, CRISPR, AACR, ADP, EVP, Roche, Clinical trial, Pharmacokinetics, Biomarker, Doctor of Philosophy, DNA repair, MD, Medicine, Therapy, ATR, Safety, Pharmaceutical industry, Nature Medicine, Reparations (transitional justice)

Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced that data from the ongoing Phase 1/2 TRESR clinical trial evaluating camonsertib (RP-3500/RG6526, partnered with Roche), a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), were published in Nature Medicine.

Key Points: 
  • Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced that data from the ongoing Phase 1/2 TRESR clinical trial evaluating camonsertib (RP-3500/RG6526, partnered with Roche), a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), were published in Nature Medicine.
  • The article, entitled “Camonsertib in DNA damage response-deficient advanced solid tumors: phase 1 trial results” can be accessed here .
  • “The results of the TRESR trial demonstrate not only the single agent activity of camonsertib, a potent and selective ATR inhibitor, but also define the importance of enhanced precision medicine approaches, such as the identification of bi-allelic alterations affecting the target DNA repair genes and other biomarkers, as well as the use of longitudinal liquid biopsies to guide its delivery to the right patients,” said Maria Koehler, MD, PhD, EVP and Chief Medical Officer of Repare.
  • Clinical data were most recently presented at the 2022 and the 2023 American Association for Cancer Research (AACR) Annual Meetings, demonstrating the promising safety and efficacy profile of camonsertib, both as a monotherapy and in combination with a poly (ADP-ribose) polymerase inhibitor.

Foundation Medicine and Its Collaborators Announce Acceptance of 21 Abstracts at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Friday, May 26, 2023
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Foundation Medicine, Inc ., today announced that the company and its collaborators will present 21 abstracts demonstrating the value of high-quality tumor profiling tests to inform cancer care at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6 in Chicago.

Key Points: 
  • Foundation Medicine, Inc ., today announced that the company and its collaborators will present 21 abstracts demonstrating the value of high-quality tumor profiling tests to inform cancer care at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6 in Chicago.
  • Two studies being presented at ASCO further define the clinical application of ctDNA monitoring and demonstrate the value of FoundationOne®Tracker to support and inform oncologists’ treatment planning.
  • Foundation Medicine will also present new data describing FoundationOne Liquid CDx’s robust ctDNA-based detection of rearrangements and fusions.
  • Follow Foundation Medicine on Twitter and LinkedIn for more updates from #ASCO23 and visit us in person at Booth #19081.

LifeSci Communications Bolsters Leadership Team

Retrieved on: 
Wednesday, April 26, 2023
LSC, Bristol Myers Squibb, Edwards Lifesciences, Wheeler, Omnicom Group, Patient, Bird, Sanofi, Growth, Merck, AofA—International Meeting on Combinatorial, Probabilistic, and Asymptotic Methods in the Analysis of Algorithms, Environment, Talazoparib, Pharmaceutical industry, Science, Pfizer

NEW YORK, April 26, 2023 (GLOBE NEWSWIRE) -- LifeSci Communications (LSC) today announced the appointment of Tim Bird as executive vice president, client services and Sarah Wheeler , senior vice president, medical communications.

Key Points: 
  • NEW YORK, April 26, 2023 (GLOBE NEWSWIRE) -- LifeSci Communications (LSC) today announced the appointment of Tim Bird as executive vice president, client services and Sarah Wheeler , senior vice president, medical communications.
  • Bird will lead LifeSci’s growing client roster and expanding team; and Wheeler will help accelerate the growth of the agency’s medical communication services.
  • He brings more than 30 years of experience in brand communications, corporate communications and reputation building.
  • “It’s exciting to leverage our unique heritage in integrated communications to support novel advances for patients.”
    Previously, Wheeler was executive vice president at BGB Group.

Financial Results for the Year Ended 31 December 2022, Publication of Annual Report & Notice of AGM

Retrieved on: 
Tuesday, April 25, 2023
Well, Talazoparib, LSE, Period, Prevalence, Q&A, Health, Casting Society of America, Biotechnology, AGM, Patient, Annual report, Form, Growth, BRCA, PARP, Safety, BST, Pyxis, Breast cancer, Cryptocurrency, Renewable energy, Pharmaceutical industry, Proxy, Powerscourt

Financial Results for the Year Ended 31 December 2022, Publication of Annual Report & Notice of AGM

Key Points: 
  • Financial Results for the Year Ended 31 December 2022, Publication of Annual Report & Notice of AGM
    Financial Results for the Year Ended 31 December 2022, Publication of Annual Report and Notice of Annual General Meeting
    LONDON, UK, 25 April 2023: Arix Bioscience plc (“Arix” or the “Company”) (LSE: ARIX), a global venture capital company focused on investing in breakthrough biotechnology companies, today announces its financial results for the full year ended 31 December 2022 (the “Period”) alongside the Annual Report and Accounts together with its Notice of 2023 Annual General Meeting (the “AGM”).
  • Markets were performing worse in the fourth quarter than in the same period in 2021 when life sciences stocks first began a steep fall.
  • In the ensuing market correction, we are seeing a more conservative environment and a flight to quality, with the market oriented more towards value.
  • Management will be hosting a live presentation and Q&A session via the online platform, Investor Meet Company, at 4:00pm BST today.

Repare Therapeutics Presents Initial Clinical Data from the Phase 1/2 TRESR and ATTACC Trials Evaluating Camonsertib in Combination with Three PARP Inhibitors at the 2023 AACR Annual Meeting

Retrieved on: 
Tuesday, April 18, 2023
Oncology, Health, Genetics, Clinical Trials, Research, Science, Biotechnology, Talazoparib, Neutropenia, Atri, DNA, Circulating tumor DNA, AACR, Febrile neutropenia, PM, Natural history, Partnership, DDR, Progression-free survival, ADP, Neoplasm, Effectiveness, Roche, Clinical trial, Therapy, Pharmacokinetics, Ataxia, Pardi, Toxicity, Doctor of Philosophy, CBR, ORR, Biomarker, MRR, MD, Patient, Anemia, AM, BRCA, Infrared spectroscopy correlation table, Ovarian cancer, PARP, Thrombocytopenia, ATR, Safety, Aplastic anemia, Disease, Pharmaceutical industry, Medical imaging, Powder metallurgy, Reparenting

We are particularly encouraged by the depth of response and duration of treatment,” said Maria Koehler, MD, PhD, Chief Medical Officer of Repare.

Key Points: 
  • We are particularly encouraged by the depth of response and duration of treatment,” said Maria Koehler, MD, PhD, Chief Medical Officer of Repare.
  • Key highlights from the data presented at the 2023 AACR Annual Meeting include:
    Camonsertib combination resulted in durable clinical benefit across tumor types and different genomic alterations, regardless of choice of PARPi and presence of platinum resistance.
  • Early ctDNA molecular responses in 66% (31/47) of evaluable patients confirms antitumor activity of low dose, intermittent PARPi + ATRi therapy.
  • The molecular response rate (MRR) was significantly higher in patients with clinical benefit (83%) compared to those without (48%; p=0.015), confirming treatment effect.

Pfizer Announces Positive TALZENNA® and XTANDI® Combination Data from Phase 3 TALAPRO-2 Study

Retrieved on: 
Thursday, February 16, 2023
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The median rPFS for the treatment arm was not reached at the time of analysis versus 21.9 months for placebo plus XTANDI.

Key Points: 
  • The median rPFS for the treatment arm was not reached at the time of analysis versus 21.9 months for placebo plus XTANDI.
  • “In addition to delaying disease progression, this combination delayed prostate-specific antigen progression and time to chemotherapy without adversely impacting patient quality of life.
  • Neither TALZENNA nor the combination of TALZENNA plus XTANDI has been approved by any regulatory agency for the treatment of mCRPC.
  • In addition to the TALAPRO-2 trial, the combination of TALZENNA plus XTANDI is being investigated in the TALAPRO-3 trial ( NCT04821622 ), a global, randomized, double-blind, placebo-controlled Phase 3 study in men with HRR-deficient metastatic castration-sensitive prostate cancer (mCSPC).

Strata Oncology Announces Expansion of Clinical Collaboration with Pfizer for Strata PATH Trial into Early-Stage Cancer

Retrieved on: 
Tuesday, September 13, 2022
Safety, NYSE, FDA, Disease, ANN, Talazoparib, Melanoma, Patient, Stata, Cancer, Axitinib, PFE, RNA, MRD, DNA, Neoplasm, Angiogenesis, Pharmaceutical industry, Medical imaging, Stratum, Pfizer

ANN ARBOR, Mich., Sept. 13, 2022 /PRNewswire/ -- Strata Oncology, Inc. a next-generation precision oncology company enabling smarter and earlier cancer treatment, today announced expansion of its clinical collaboration with Pfizer (NYSE: PFE) in the Strata Precision Indications for Approved THerapies (Strata PATHTM) trial. Strata PATH is a prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. Pfizer will provide Braftovi® (encorafenib), Mektovi® (binimetinib), and Lorbrena® (lorlatinib) for up to six new cohorts of patients with early-stage lung, melanoma, colorectal, and other cancers who have evidence of micrometastatic disease after initial treatment. Pfizer is already providing Strata with Braftovi® (encorafenib), Mektovi® (binimetinib), Lorbrena® (lorlatinib), Talzenna® (talazoparib), and Inlyta (axitinib) for evaluation in four late-stage cohorts of the Strata PATH trial.

Key Points: 
  • a next-generation precision oncology company enabling smarter and earlier cancer treatment, today announced expansion of its clinical collaboration with Pfizer (NYSE: PFE) in the Strata Precision Indications for Approved THerapies (Strata PATHTM) trial.
  • Strata PATH is a prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations.
  • Pfizer is already providing Strata with Braftovi (encorafenib), Mektovi(binimetinib), Lorbrena (lorlatinib), Talzenna (talazoparib), and Inlyta (axitinib) for evaluation in four late-stage cohorts of the Strata PATH trial.
  • Strata Oncology, Inc. is a precision oncology company dedicated to delivering the best possible treatment for each patient with cancer.