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US FDA grants breakthrough therapy designation to Daiichi Sankyo & Merck's raludotatug deruxtecan for patients with CDH6 expressing platinum─resistant ovarian, primary peritoneal, or fallopian tube cancers previously treated with bevacizumab
16 Sep 2025 04:05 GMT
… the US Food and Drug Administration (FDA) for the treatment of adult patients … 1 trial was presented at the 2023 European Society for Medical Oncology … , pegylated liposomal doxorubicin, gemcitabine or topotecan). The dual primary endpoints of …
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FDA Grants Breakthrough Therapy Designation to R-DXd in Gynecologic Cancers
15 Sep 2025 17:57 GMT
… FDA has granted breakthrough therapy designation to the novel antibody-drug … and fill unmet medical needs. The designation … -Ovarian01 trial (NCT06161025).
“Patients have limited treatment options … liposomal doxorubicin, or topotecan in part B.
Patients …
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<![CDATA[FDA Grants Breakthrough Therapy Designation to R-DXd in CDH6-Expressing Ovarian Cancer]]>
15 Sep 2025 22:47 GMT
… directed antibody-drug conjugate (ADC), for the treatment of adult … , randomized, open-label trial assessing the efficacy and … liposomal doxorubicin, gemcitabine, or topotecan). The dual primary end … medical meeting and to continue working closely with the FDA …
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Non-Coding RNAs Crucial in Topotecan Cancer Response
13 Sep 2025 09:07 GMT
… patient outcomes through precision medicine approaches.
Therapeutically, … reshaping Topotecan sensitivity over the course of treatment. This … early-phase clinical trials exploring such combinatorial … ncRNA biology and innovative biotechnologies.
In summation, …
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<![CDATA[Investigational PD-L1 x VEGF-A Bispecific Antibody Demonstrates Strong Overall Response Rate in Phase II Small Cell Lung Cancer Trial]]>
11 Sep 2025 17:43 GMT
… Phase III trial (ROSETTA-LUNG-01) and has received FDA Orphan Drug designation … thoracic/head and neck medical oncology, University of Texas MD … or topotecan for patients in the second- or third-line treatment setting …
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WCLC: Daiichi’s I-DXd shows 48.2% ORR in ES-SCLC trial
08 Sep 2025 12:57 GMT
… cancer (ES-SCLC) trial.
During the Phase II … SoC) treatments.
Upon its potential US Food and Drug Administration (FDA) approval … dominance of Zepzelca and topotecan in this patient population … content on Pharmaceutical Technology (Or Clinical Trials Arena) is …
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Rina-S Earns FDA Breakthrough Therapy Designation in Endometrial Cancer
26 Aug 2025 22:15 GMT
… wholly owned antibody medicines in areas long … , prognosis worsens and treatment options become increasingly limited … their choice of paclitaxel, topotecan, pegylated liposomal doxorubicin, … RAINFOL-02 trial (NCT06619236).4
Genmab receives FDA breakthrough …
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<![CDATA[Reducing Chemotherapy Toxicity Using Trilaciclib in SCLC]]>
22 Sep 2025 18:11 GMT
… of clinical medicine and translational medical oncologist at … , improving patients' treatment experience and outcomes.
Register … out, with topotecan. It received the FDA approval for … has ended) and Jazz Pharmaceuticals (relationship has ended), and …
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New Trials Advance Treatments for Lymphoma, Lung Cancer and Sarcomas
25 Jul 2025 21:47 GMT
… lung cancer. Several clinical trials have reached important milestones … 2a trial is enrolling people with relapsed or treatment-resistant … temozolomide, or cyclophosphamide plus topotecan in pediatric patients with … linked to other drugs.
The ALKAZAR trial is a …
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Predictive Value of the KELIM Index for Progression-Free Survival in Ovarian Cancer Under Current Treatment Modalities
23 Jul 2025 11:48 GMT
… been approved by the Medical Ethics Committee of the … or Enrollment in clinical trials exploring novel agents for … .
Maintenance treatment refers to the use of drugs to delay … trial of topotecan following carboplatin and paclitaxel in first-line treatment …