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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FDA Grants Priority Review to Lifileucel in Advanced Melanoma
May 30th 2023The FDA has granted priority review to the biologics license application for the tumor infiltrating lymphocyte therapy lifileucel for the treatment of patients with advanced melanoma who progressed on or after prior anti–PD-1/PD-L1 therapy and targeted therapy.
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Durvalumab Plus Chemotherapy With or Without Olaparib Improves PFS in Advanced Endometrial Cancer
May 26th 2023The combination of durvalumab and platinum-based chemotherapy, followed by maintenance therapy with either durvalumab plus olaparib or durvalumab alone, elicited a statistically significant and clinically meaningful improvement in progression-free survival in patients with newly diagnosed, advanced or recurrent endometrial cancer.
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Pembrolizumab plus chemotherapy with or without bevacizumab led to a substantial improvement in overall survival vs placebo plus chemotherapy with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer, according to the final OS analysis of the KEYNOTE-826 trial.
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Sitravatinib Plus Nivolumab Fails to Meet OS End Point in Nonsquamous NSCLC
May 25th 2023The combination of sitravatinib and nivolumab did not meet the primary end point of overall survival compared with docetaxel as second- or third-line treatment for patients with advanced nonsquamous non–small cell lung cancer who progressed on prior chemotherapy and immune checkpoint inhibitor therapy.
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Voruciclib With or Without Venetoclax Shows Safety, Activity in R/R AML, B-cell Malignancies
May 24th 2023Voruciclib monotherapy and in combination with venetoclax demonstrated clinical activity and was well tolerated with no significant myelosuppression in heavily pretreated patients with relapsed/refractory acute myeloid leukemia or B-cell malignancies, according to initial data from a phase 1 trial.
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The National Institute for Health and Care Excellence has recommended the combination of pembrolizumab and lenvatinib for use in previously treated patients with advanced or recurrent endometrial cancer whose cancer has progressed on or after platinum-based chemotherapy and who cannot have curative surgery or radiotherapy.
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Milademetan Fails to Meet PFS End Point in Dedifferentiated Liposarcoma
May 22nd 2023Treatment with milademetan did not lead to a statistically significant improvement in progression-free survival compared with trabectedin in patients with dedifferentiated liposarcoma, failing to reach the primary end point of the phase 3 MANTRA trial.
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First-line Eftilagimod Alpha Plus Pembrolizumab Generates OS Benefit in PD-L1+ NSCLC
May 17th 2023Eftilagimod alpha plus pembrolizumab provided an overall survival benefit over what has been reported with historical controls when given as first-line treatment in patients with non–small cell lung cancer and a PD-L1 tumor proportion score of at least 1%.
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Osimertinib Plus Chemotherapy Improves PFS in EGFR+ Advanced NSCLC
May 17th 2023The combination of osimertinib and platinum-based chemotherapy led to a statistically significant and clinically meaningful improvement in progression-free survival compared with osimertinib alone in patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR mutations.
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IBI351 Receives Breakthrough Therapy Designation in China for Previously Treated Advanced CRC
May 16th 2023China’s National Medical Products Administration has granted a breakthrough therapy designation to the KRAS G12C inhibitor IBI351 as monotherapy for previously treated patients with advanced colorectal carcinoma harboring a KRAS G12C mutation.
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FDA Issues Complete Response Letter for Trastuzumab Duocarmazine in Advanced HER2+ Breast Cancer
May 15th 2023The FDA has issued a complete response letter to the biologics license application for vic-trastuzumab duocarmazine for the treatment of patients with HER2-positive unresectable, locally advanced or metastatic breast cancer.
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Neoadjuvant Atezolizumab Plus Chemotherapy Numerically Improves Survival in Early TNBC
May 12th 2023The addition of atezolizumab to neoadjuvant chemotherapy generated numerical improvements in event-free survival, disease-free survival, and overall survival compared with chemotherapy plus placebo in patients with early-stage triple-negative breast cancer.
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FDA Issues Complete Response Letter to BLA for N-803 in BCG-unresponsive NMIBC in Situ
May 11th 2023The FDA has issued a complete response letter regarding the biologics license application for N-803 in combination with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease.
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Ivosidenib Wins European Approval for IDH1-mutated AML and Cholangiocarcinoma
May 10th 2023The European Commission has approved ivosidenib tablets in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukemia with an IDH1 R132 mutation who are not eligible to receive standard induction chemotherapy, and as monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who received at least 1 prior line of systemic therapy.
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China Approves Zanubrutinib in Previously Untreated CLL/SLL and Waldenström Macroglobulinemia
May 8th 2023China’s National Medical Products Administration has approved 2 supplemental new drug applications of zanubrutinib for use in treatment-naïve adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma and Waldenström macroglobulinemia.
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Sintilimab Plus Chemo With or Without IBI305 Provides PFS Benefit in EGFR TKI–Pretreated EGFR+ NSCLC
May 8th 2023The combination of sintilimab and chemotherapy with or without the bevacizumab biosimilar IBI305 produced a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with EGFR-mutated, nonsquamous non–small cell lung cancer who progressed after treatment with an EGFR TKI.
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FDA Grants 501K Clearance to Bladder EpiCheck for Surveillance in NMIBC
May 5th 2023The FDA has granted 510K clearance to Bladder EpiCheck for use as a noninvasive method for surveillance of tumor recurrence in previously diagnosed patients with non–muscle invasive bladder cancer, in conjunction with cystoscopy.
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Liso-cel Earns European Approval for Relapsed/Refractory LBCL After 1 Prior Therapy
May 3rd 2023The European Commission has approved lisocabtagene maraleucel for the treatment of adult patients with diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
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First-line Cemiplimab Plus Chemo Wins Approval in Canada for Advanced NSCLC
May 2nd 2023Health Canada has approved the combination of cemiplimab and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic non–small cell lung cancer without EGFR, ALK, or ROS1 aberrations who are not candidates for definitive chemoradiation.
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FDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS
May 1st 2023The FDA has granted a priority review to the supplemental biologics license application seeking to expand the current indication of luspatercept to include treatment of anemia in patients with very low- to intermediate-risk myelodysplastic syndrome who have not previously received erythropoiesis-stimulating agents and who may require red blood cell transfusions.
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AUA Releases Clinical Practice Guideline for Nonmetastatic Upper Tract Urothelial Carcinoma
April 27th 2023The American Urological Association and Society of Urologic Oncology have released a clinical practice guideline for the diagnosis and management of patients with nonmetastatic upper tract urothelial carcinoma.
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ASTRO/ESTRO Release Clinical Guideline for Local Therapy in Oligometastatic NSCLC
April 26th 2023The American Society for Radiation Oncology and European Society for Radiotherapy & Oncology have released the first clinical guideline on the use of definitive local therapy, including radiation and surgery, for the treatment of patients with oligometastatic non–small cell lung cancer.
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