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Choosing Clinical End Points in China for US Bridging Studies
19 Jun 2025 19:32 GMT
… prior larger registrational trials have already demonstrated durable … Pharma/Henlius Biotech.6,7 SAF-189s … crizotinib (Xalkori) in treatment-naive patients with ALK-positive NSCLC. The trial … cancer drugs and biologics guidance for industry. FDA. December …
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FDA clears Nuvation's first product Ibtrozi, for lung cancer
12 Jun 2025 12:58 GMT
… the FDA approved its ROS1 inhibitor Ibtrozi as a treatment for … "major milestone" in treatment, adding that Ibtrozi (taletrectinib) … s first-to-market Xalkori (crizotinib), Roche's Rozlytrek … drug has been approved on the back of two phase 3 trials …
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FDA Approves Taletrectinib in ROS1+ NSCLC
11 Jun 2025 17:43 GMT
… received prior treatment with crizotinib (Xalkori). The TRUST-II trial enrolled patients … TRUST-I and TRUST-II trials, including those who were … in December 2024.4
FDA approves taletrectinib for ROS1 … U.S. Food and Drug Administration accepts for priority …
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FDA Approves Taletrectinib for ROS1+ Advanced NSCLC
11 Jun 2025 23:27 GMT
… TRUST-II (NCT04919811) trials.1 Treatment-naive patients experienced an … in China during the trial. TRUST-II was … in the form of crizotinib or entrectinib (Rozlytrek). … ;www.fda.gov/drugs/;resources-information-approved-drugs/fda-approves- …
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FDA Backs Darovasertib Phase 3 Trial Design in Uveal Melanoma
14 Apr 2025 23:38 GMT
… second registrational trial," said Darrin Beaupre, MD, PhD, chief medical officer … crizotinib (Xalkori) in metastatic uveal melanoma in December 2022.2 The FDA … orphan drug designation for darovasertib, a PKC inhibitor, for the treatment of …
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Pfizer’s ALK lung cancer drug Lorviqua lands 1st-line reimbursement in Korea
02 May 2025 01:42 GMT
… lorlatinib) as a first-line treatment for ALK-positive metastatic non … its proven edge over older drugs like crizotinib.
Lorviqua targets a gene … Department of Oncology at Asan Medical Center said in a … the global phase 3 CROWN trial, Pfizer’s Lorviqua reduced …
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Mechanisms of Resistance to ALK Inhibitors and Corresponding Treatment Strategies in Lung Cancer
15 Apr 2025 14:11 GMT
… involved in primary drug resistance after crizotinib treatment, as demonstrated by … entered phase II clinical trials and is expected to … NSCLC.159
Others
Tumor vaccine is a cell fragment … Laboratory of Nuclear Technology Medical Transformation (Mian yang Central …
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Taletrectinib Data Published as FDA Weighs Approval for ROS1+ NSCLC
08 Apr 2025 23:42 GMT
… once daily. Common treatment-emergent adverse events … Medical Oncology Congress.3 Under the Prescription Drug User Fee Act, the FDA … trial (NCT06564324) will be comparing taletrectinib head-to-head with crizotinib … pivotal phase II trials of taletrectinib in …
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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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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 …