FDA Grants Priority Review to Zolbetuximab for CLDN18.2+ Advanced Gastric/GEJ Adenocarcinoma
July 6th 2023The FDA has granted a priority review to the biologics license application seeking the approval of zolbetuximab for the first-line treatment of patients with unresectable, locally advanced or metastatic, HER2-negative, gastric or gastroesophageal junction adenocarcinoma whose tumors are Claudin18.2 positive.
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FDA Approves Ready-to-Dilute Cyclophosphamide Injection for Various Cancers
July 5th 2023The FDA has approved a new drug application for 200-mg/mL vials of cyclophosphamide injection for use in combination therapy in the treatment of patients with various types of cancers, including malignant lymphoma, multiple myeloma, and various types of leukemia.
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Datopotamab Deruxtecan Significantly Improves PFS in Advanced NSCLC
July 5th 2023Datopotamab deruxtecan provided a statistically significant improvement in progression-free survival compared with standard-of-care docetaxel in patients with locally advanced or metastatic non–small cell lung cancer who received at least 1 prior line of therapy.
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Intra-arterial Gemcitabine Improves OS in Locally Advanced Pancreatic Cancer
June 29th 2023Treatment with intra-arterial gemcitabine led to an improvement in overall survival compared with continued treatment with intravenous gemcitabine plus nab-paclitaxel in patients with locally advanced pancreatic cancer following sequential treatment with IV gemcitabine, nab-paclitaxel, and radiotherapy.
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Neoadjuvant Nivolumab/Chemo Wins EU Approval for Resectable PD-L1+ NSCLC
June 29th 2023The European Commission has approved nivolumab in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable non–small cell lung cancer at high risk of recurrence with tumor cell PD-L1 expression of at least 1%.
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Development of FHD-286 Monotherapy Will Not Continue in Metastatic Uveal Melanoma
June 29th 2023Although the highly potent, selective, allosteric, oral, small molecule BRG1/BRM inhibitor FHD-286 elicited signs of clinical activity and safety as monotherapy in patients with metastatic uveal melanoma in the dose-escalation portion of a phase 1 trial, further development in this indication will not be pursued.
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First-line Mitazalimab Plus Chemo Continues to Generate Responses in Metastatic PDAC
June 27th 2023Frontline treatment with the combination of the CD40-directed monoclonal antibody agonist mitazalimab and modified FOLFIRINOX continued to produce responses in patients with metastatic pancreatic ductal adenocarcinoma.
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Zanubrutinib Maintains PFS Benefit With Extended Follow-Up in Previously Untreated CLL/SLL
June 21st 2023Extended follow-up from the phase 3 SEQUOIA trial demonstrated that zanubrutinib maintained a progression-free survival benefit compared with bendamustine plus rituximab in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
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Neoadjuvant treatment with pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab plus chemotherapy, then pembrolizumab monotherapy, led to a statistically significant improvement in pathological complete response rates vs neoadjuvant chemotherapy alone in patients with locally advanced, resectable gastric and gastroesophageal junction adenocarcinoma.
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FDA Accepts sNDA for Frontline NALIRIFOX in Metastatic Pancreatic Ductal Adenocarcinoma
June 14th 2023The FDA has accepted a supplemental new drug application seeking approval of the NALIRIFOX regimen comprised of irinotecan liposome injection plus 5-fluorouracil, leucovorin, and oxaliplatin as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma.
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Phase 1 Trial of SC-DARIC33 in Pediatric R/R CD33+ AML on Hold After Serious Grade 5 AE
June 14th 2023The phase 1 PLAT-08 trial investigating SC-DARIC33 in pediatric and young-adult patients with relapsed/refractory CD33-positive acute myeloid leukemia has been paused following the report of a grade 5 serious adverse effect.
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Brentuximab Vedotin Plus Nivolumab/Chemo Elicits 98% ORR in Early-Stage Classical Hodgkin Lymphoma
June 13th 2023Frontline treatment with the combination of brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine led to an overall response rate of 98% and a complete response rate of 93% in patients with early-stage, classical Hodgkin lymphoma.
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Cevidoplenib Elicits Platelet Responses in Persistent or Chronic Immune Thrombocytopenia
June 11th 2023The novel SYK inhibitor cevidoplenib dosed at 400 mg twice per day led to robust platelet responses in patients with persistent or chronic primary immune thrombocytopenia who did not respond or relapsed after at least 1 prior therapy.
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Ponatinib Plus Reduced-intensity Chemo Could Be New SOC in Newly Diagnosed Ph+ ALL
June 9th 2023Treatment with ponatinib plus reduced-intensity chemotherapy led to an improvement in minimal residual disease-negative complete remission rate compared with imatinib plus reduced-intensity chemotherapy in newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia.
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Resection Should be Considered for Residual Non-Retroperitoneal Disease in Post-Chemo NSGCTs
June 8th 2023Although patients with metastatic nonseminomatous germ-cell tumors who had teratoma in the primary tumor were found to have a higher rate of teratoma in residual non-retroperitoneal disease following chemotherapy, those without teratoma in the primary tumor could have teratoma or active testicular germ-cell tumors in residual disease post-chemotherapy and should be considered for resection.
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Majority of US Cancer Centers Report Shortages of Cisplatin/Carboplatin Chemotherapy
June 7th 2023A survey conducted by the National Comprehensive Cancer Network Best Practices Committee found that 93% of United States cancer centers polled in the report are experiencing a shortage of carboplatin, and 70% currently have a shortage of cisplatin.
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Pembrolizumab Plus Chemo Does Not Significantly Improve Survival in TKI-resistant, EGFR+ NSCLC
June 6th 2023The addition of pembrolizumab to pemetrexed and platinum-based chemotherapy resulted in a numerical, but not statistically significant, improvement in progression-free survival or overall survival vs chemotherapy plus placebo in patients with TKI-resistant, EGFR-mutated, metastatic nonsquamous non–small cell lung cancer.
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Cilta-cel Possesses Potential to Be New SOC for Lenalidomide-refractory Myeloma After First Relapse
June 5th 2023Ciltacabtagene autoleucel significantly improved progression-free survival over standard-of-care pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone in patients with lenalidomide-refractory multiple myeloma who received 1 to 3 prior lines of therapy.
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Adjuvant Osimertinib Provides OS Benefit in EGFR+ Stage IB-IIIA NSCLC
June 4th 2023Treatment with adjuvant osimertinib produced a statistically significant and clinically meaningful improvement in overall survival compared with placebo in patients with resected, EGFR-mutated, stage IB to IIIA non–small cell lung cancer.
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Elranatamab Elicits Responses in Relapsed/Refractory Myeloma After Prior BCMA-directed Therapy
June 4th 2023Treatment with elranatamab monotherapy produced early, deep, and durable responses in patients with relapsed/refractory multiple myeloma who received a prior BCMA-directed therapy, according to a pooled analysis of the MagnetisMM-1, MagnetisMM-2, MagnetisMM-3, and MagnetisMM-9 trials.
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