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PRINCETON: BRISTOL MYERS SQUIBB has issued the following news release: Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for [...]

Approval based on results from the Phase 1/2 KRYSTAL-1 study where KRAZATI in combination with cetuximab showed an objective response rate of 34% in pretreated patients with locally advanced or [...]

USA News Group CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 19, 2024 /PRNewswire/ -- https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ -- This year's https://www.labiotech.eu/in-depth/asco-2024-latest-advances-in-oncology-clinical-trials/ of theAmerican Society of Clinical Oncology (ASCO) has [...]

PRINCETON: Bristol Myers Squibb has issued the following news release: Bristol Myers Squibb (NYSE: BMY) today announced results from the Phase 3 KRYSTAL-12 study evaluating KRAZATI(r) (adagrasib) compared to standard [...]

Late-breaking exploratory analysis of the CheckMate -77T study of perioperative Opdivo shows improved event-free survival and pathologic complete response in stage III resectable NSCLC patients regardless of nodal status Four-year [...]

ENPNewswire-April 2, 2024--Zai Lab Partner Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI Meets Primary Endpoint (C)2024 ENPublishing - http://www.enpublishing.co.uk Release date- 01042024 - SHANGHAI, CAMBRIDGE - Zai [...]

SHANGHAI & CAMBRIDGE, Mass. -- Zai Lab Partner Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRAS(G12C)-Mutated [...]

PRINCETON: Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRASG12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung [...]

PRINCETON, N.J. -- Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRAS(G12C)-Mutated Locally Advanced or Metastatic Non-Small [...]

ENPNewswire-February 21, 2024--Bristol Myers Squibb - U.S. Food and Drug Administration Accepts Supplemental New Drug Application for KRAZATI in Combination with Cetuximab as a Targeted Treatment Option for Patients with [...]

Bristol Myers Squibb announced on 20 Feb 2024 that the US Food and Drug Administration (FDA) has accepted for priority review the supplemental new drug application (sNDA) for Krazati (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of 21 Jun 2024. The submission is based on the results of KRYSTAL-1 study, a multicohort trial which evaluated KRAZATI alone or in combination with other anticancer therapies in patients with advanced solid tumours harbouring a KRASG12C mutation. The primary endpoint for the registrational cohort was objective response rate. The secondary endpoints for the pooled cohorts included duration of response, progression-free survival, overall survival and safety. Results of the KRYSTAL-1 study showed that KRAZATI was well tolerated and provided promising clinical activity in pretreated patients with locally advanced or metastatic CRC harbouring a KRASG12C mutation. The safety profile for Krazati plus cetuximab was manageable and consistent with previous reports, and with the known safety profile of each drug individually. Original source: Bristol-Myers Squibb, website: http://www.bms.com/, Copyright Bristol-Myers Squibb 2024., regulations and rulings; adagrasib; anticancer drugs; cetuximab; Krazati; Bristol Myers [...]

U.S. FDA has assigned a target action date of June 21, 2024 Application based on results from the Phase 1/2 KRYSTAL-1 study PRINCETON, N.J. -- U.S. Food and Drug Administration [...]

PRINCETON, N.J.--(BUSINESS WIRE)--Feb 20, 2024-- U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for KRAZATI ® (adagrasib) in Combination with Cetuximab as a Targeted Treatment Option for [...]

Bristol Myers Squibb (BMS) announced on 23 Jan 2024 that it has successfully completed its acquisition of Mirati Therapeutics Inc ('Mirati'). With the completion of the acquisition, Mirati shares have ceased trading on the NASDAQ Global Select Market and Mirati is now a wholly owned subsidiary of BMS. Through this transaction, BMS has added commercialized lung cancer medicine Krazati (adagrasib) to its oncology portfolio as well as several promising clinical assets, including a potential first-in-class MTA-cooperative PRMT5 inhibitor in Phase 1 development, and a leading KRAS and KRAS enabling programme with two candidates in Phase 1 development. The transaction is expected to be treated as a business combination and to be dilutive to BMS' non-GAAP earnings per share by approximately $0.35/share in 2024. Original source: Bristol-Myers Squibb, website: http://www.bms.com/, Copyright Bristol-Myers Squibb 2024., mergers and acquisitions; adagrasib; anticancer drugs; enzyme inhibitors; Krazati; Bristol Myers Squibb (BMS); Mirati [...]

SAN DIEGO: Mirati Therapeutics, Inc. has issued the following news release: Mirati Therapeutics, Inc.(r) (NASDAQ: MRTX), a commercial stage biotechnology company, announced that the European Commission (EC) granted conditional marketing [...]

ENPNewswire-January 11, 2024--Mirati Therapeutics - European Commission Approves KRAZATI as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer with a KRASG12C Mutation (C)2024 ENPublishing - http://www.enpublishing.co.uk [...]

SAN DIEGO and ZUG, Switzerland, Jan. 10, 2024 /PRNewswire/ -- https://c212.net/c/link/?t=0&l=en&o=4064737-1&h=1009758736&u=https%3A%2F%2Fwww.mirati.com%2F&a=Mirati+Therapeutics%2C+Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, today announced that the European Commission (EC) granted conditional marketing authorization for [...]

The global market for Kirsten rat sarcoma viral oncogene homologue (KRAS)-targeting drugs in oncology is set to reach over $4 bn by 2029, forecasts GlobalData, a leading data and analytics company. GlobalData's Pharmaceutical Intelligence Center reveals that Mirati Therapeutics is expected to emerge as the leader in this rapidly expanding market, as its small-molecule KRAS G12C inhibitor Krazati is anticipated to secure a 30.7% market share with worldwide sales of $1.2 bn by 2029. Following closely behind Mirati, Amgen's Lumakras is predicted to attain the second spot with $1 bn sales, representing 25.4% of the overall KRAS-targeting therapy market share by 2029. According to GlobalData's patient-based forecast, the total sales of Krazati and Lumakras will reach $1.4 bn for non-small cell lung cancer (NSCLC) treatment by 2029 in the eight major markets (US, France, Germany, Italy, Spain, UK, Japan, and China). In addition, these two drugs are in multiple clinical trials for several solid cancers, including colorectal cancer, pancreatic cancer, breast cancer, ovarian cancer, and bile duct cancer. To date, the FDA has only approved two commercial KRAS inhibitor drugs for cancer treatment. However, the sector has seen substantial expansion since 2019, with 110 distinct Phase I-III trials employing different KRAS-targeting therapies. In 2020 and 2021, there were 14 and 33 ongoing trials, respectively, showing a clear growth trend. This upward trajectory continued into 2022 and 2023, with each year witnessing 51 ongoing trials, demonstrating an active pipeline and a steadfast commitment to developing KRAS-targeting treatments. Along with KRAS inhibitors like Roche's divarasib and Novartis' opnurasib, Revolution Medicines is also in the race to bring about significant changes with three different KRAS inhibitors in the pipeline. One of Revolution Medicines' G12C mutant-selective KRAS inhibitors is RMC-6291. It has a different mechanism of action than the approved KRAS inhibitors Krazati and Lumakras, targeting the inactive KRAS state. RMC-6291 acts as a 'molecular glue'. It binds to cyclophilin A, a ubiquitous protein that forms a complex with KRAS G12C in its active state. A bar graph shows the sales forecast for top 10 KRAS inhibitor drugs in cancer treatment by 2029. Original source: Global Data, website: http://www.energy.globaldata.com, Copyright Global Data 2023., market; research and development; sales; anticancer drugs; divarasib; Krazati; Lumakras; opnurasib; Amgen; Mirati Therapeutics; Novartis; Revolution Medicines; [...]

SAN DIEGO: Mirati Therapeutics, Inc. has issued the following news release: Mirati Therapeutics, Inc.(r) (NASDAQ: MRTX), a commercial stage biotechnology company, today announced that following a re-examination procedure, the Company [...]

ENPNewswire-November 7, 2023--Mirati Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Updates (C)2023 ENPublishing - http://www.enpublishing.co.uk Release date- 06112023 - SAN DIEGO - Mirati Therapeutics, Inc. (NASDAQ: MRTX), [...]

SAN DIEGO, Nov. 6, 2023 /PRNewswire/ -- https://c212.net/c/link/?t=0&l=en&o=4016426-1&h=422520604&u=http%3A%2F%2Fwww.mirati.com%2F&a=Mirati+Therapeutics%2C+Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the third quarter 2023 along with recent pipeline and corporate [...]

SAN DIEGO: Mirati Therapeutics, Inc., a commercial stage biotechnology company, announced the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization approval for KRAZATI(r) (adagrasib) as [...]

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (3 November 2023) authorised a new medicine called Krazati (adagrasib), a treatment for a type of non-small cell lung cancer [...]

London: UK Government has issued the following news release: Patients with a certain type of advanced or spreading non-small cell lung cancer (NSCLC) could access a new cancer therapy to [...]