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Taletrectinib Data Published as FDA Weighs Approval for ROS1+ NSCLC
08 Apr 2025 23:42 GMT
… mg once daily. Common treatment-emergent adverse events (TEAEs)— … Medical Oncology Congress.3 Under the Prescription Drug User Fee Act, the FDA … population had prior crizotinib (Xalkori) and 8.8% had … 2 pivotal phase II trials of taletrectinib in patients …
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FDA Grants Breakthrough Therapy to IDE196 in Primary Uveal Melanoma
04 Apr 2025 21:15 GMT
… States Food and Drug Administration (FDA) for the neoadjuvant treatment of adult patients … ;3 registration-enabling trial of the IDE196 and Xalkori combination in 1L … Therapy designation application at multiple medical conferences in 2025," Yujiro …
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Neoadjuvant Darovasertib Receives FDA Breakthrough Therapy Designation for Uveal Melanoma
03 Apr 2025 17:04 GMT
… present updated data from this trial at medical meetings in mid-2025 … FDA fast track designation that was granted to darovasertib plus crizotinib (Xalkori … , the FDA granted orphan drug designation to darovasertib for the treatment of patients …
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FDA Grants Breakthrough Therapy Designation to Darovasertib in Melanoma
31 Mar 2025 23:19 GMT
… findings from a phase 2 trial (NCT05907954) evaluating neoadjuvant … unmet medical need where there are currently no FDA-approved … crizotinib (Xalkori) in December 2022 for the potential treatment of … and an orphan drug designation from the FDA in May 2022 …
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Considerations for TKI Selection and Sequencing in ALK-Positive NSCLC
07 Apr 2025 23:18 GMT
… and second lines of treatment for patients with stage … in the Department of Medical Oncology & Therapeutics Research … CROWN trial?
Kim: The CROWN trial [assessed] lorlatinib vs crizotinib [Xalkori]. … being studied in clinical trials that can, in fact …
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Pharmac to fund more cancer medicines
18 Mar 2025 20:46 GMT
… come back after prior treatment
crizotinib (branded as Xalkori) for a type … Manager Pharmaceuticals Adrienne Martin says these medicines will give people more treatment options …
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ROZLYTREK's Market Growth Reflects Transforming Treatment for NTRK and ROS1-Positive Cancers | DelveInsight
12 Mar 2025 21:58 GMT
… ANS03 (Avistone Biotechnology), Zanidatamab (Jazz Pharmaceuticals), PT- … FDA has also granted accelerated approval to ROZLYTREK for the treatment … medicine segment. As personalized oncology continues to gain traction, the drug …
Clinical Trials Information
2. …
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Pharmac Funding Decision Will Increase Medicines Access
12 Mar 2025 02:45 GMT
… cancer, including a
combination treatment, and one medicine for antibiotic
resistant infections … spread at any point of
treatment,
inotuzumab ozogamicin (branded as
Besponsa … come back after prior
treatment,
crizotinib (branded as Xalkori) for a
type …
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FDA Approval of Ensacove Adds to the Toolkit for ALK-Positive NSCLC
07 Mar 2025 01:15 GMT
… by the Food and Drug Administration (FDA) for adults with anaplastic … or Xalkori (crizotinib).
According to findings from the trial published … approved for treatment either as a first treatment after newly … on what you and your doctor discuss.”
For more news …
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October - December 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
05 Mar 2025 21:57 GMT
… Pharmaceutical Company at the retail level.
Alunbrig (brigatinib)
Xalkori … Patient Counseling Information”, and “Medication Guide” sections of the … acid hydrochloride
Hypersensitivity
FDA is evaluating the … and the amount of drug available in the …