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FDA Grants Breakthrough Therapy to IDE196 in Primary Uveal Melanoma
04 Apr 2025 21:15 GMT
… Food and Drug Administration (FDA) for the neoadjuvant treatment of … in combination with Xalkori (crizotinib) for adult patients being … phase 3 registrational trial in patients with … designation application at multiple medical conferences in 2025,…
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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 … References
IDEAYA Biosciences receives US FDA breakthrough therapy designation for … Crizotinib-for-the-Treatment-of-Metastatic-Uveal-Melanoma
IDEAYA Biosciences receives orphan drug …
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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 … an orphan drug designation from the FDA in May 2022 … combination therapy with crizotinib for the treatment of metastatic uveal …
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IDEAYA Gets FDA Breakthrough Therapy Designation For Darovasertib In Neoadjuvant UM; Stock Up
31 Mar 2025 14:22 GMT
… preservation / improvement on treatment, were submitted as part … registration-enabling trial of the darovasertib and crizotinib combination in … designated as an Orphan Drug by the regulator in … unmet medical need where there are currently no FDA-approved …
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IDEAYA Biosciences Receives US FDA Breakthrough Therapy Designation For Darovasertib Monotherapy In Neoadjuvant Uveal Melanoma
31 Mar 2025 11:48 GMT
… -enabling trial of the darovasertib and crizotinib combination … existing treatments. The designation facilitates more intensive FDA guidance … class of precision medicine targets.
Forward-Looking … preclinical and clinical trials, the regulatory approval …
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Integrating Lorlatinib Into First-Line ALK-Positive NSCLC Treatment
29 Mar 2025 21:33 GMT
… , MS, associate professor of medicine and director of Thoracic Oncology … . When we do clinical trials, we rarely see HRs … with this drug?
Patel: Lorlatinib is a reasonable treatment approach for … et al. Lorlatinib versus crizotinib in patients with advanced ALK …
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Nuvation Bio to Present Matching-adjusted Indirect Comparison Data for Taletrectinib vs. Crizotinib During Mini Oral Presentation at the European Lung Cancer Congress 2025
25 Mar 2025 12:23 GMT
… comparison study evaluating taletrectinib versus crizotinib in ROS1-positive (ROS1 … studies, the U.S. FDA has accepted and granted … , and Orphan Drug Designation for the treatment of patients with … ’s leading prostate cancer medicines. Nuvation Bio has offices …
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Pharmac to fund more cancer medicines
18 Mar 2025 20:46 GMT
… has come back after prior treatment
crizotinib (branded as Xalkori) for … for treatment.
Pharmac’s Manager Pharmaceuticals Adrienne Martin says these medicines will … give people more treatment …
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Pharmac Funding Decision Will Increase Medicines Access
12 Mar 2025 02:45 GMT
… a
combination treatment, and one medicine for antibiotic
resistant … worsened
after trying other medicines,
sunitinib for kidney … come back after prior
treatment,
crizotinib (branded as Xalkori) … and that requires world-class medicines,”
Mr Seymour
says.
…
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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 in … approved for treatment either as a first treatment after newly … what you and your doctor discuss.”
For more news …