November 5th 2024
Despite regulatory challenges from the FDA, odronextamab has received European approval for the treatment of patients with relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma following 2 prior treatments.
Pontchartrain Cancer Center Pushes Limits of Community Care in Southeast Louisiana
September 27th 2018Pontchartrain Cancer Center was founded in 2005 to serve an area of Louisiana that lacked the necessary resources for cancer care. This community cancer center, with 2 locations in Southeast Louisiana, accommodates any patient to walk through its doors, filling a major unmet need for the community in this rural area.
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Duvelisib Granted FDA Approval for CLL and Follicular Lymphoma
September 25th 2018Duvelisib (Copiktra) has been approved by the FDA for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or relapsed/refractory follicular lymphoma. Both indications are for the treatment of patients who have received at least 2 prior therapies.
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Axicabtagene Ciloleucel Gains Approval in Europe for DLBCL, PMBCL
August 28th 2018Axicabtagene ciloleucel (axi-cel; Yescarta) has been approved by the European Commission as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma, following at least 2 lines of systemic therapy.
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Tisagenlecleucel Granted Approval in Europe for DLBCL, ALL
August 27th 2018Tisagenlecleucel has gained approval from the European Commission as a treatment for adult patients with diffuse large B-cell lymphoma that is relapsed or refractory after 2 or more lines of systemic therapy, or patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse posttransplant, or in second or later relapse.
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Targeting EZH2 Delivers Promising Activity in Lymphomas
August 17th 2018Targeting EZH2, the catalytic subunit of the multiprotein PRC2, may represent an attractive therapeutic objective in malignant lymphoma, Vincent Ribrag, MD, told his audience at the American Association for Cancer Research’s inaugural Advances in Malignant Lymphoma meeting.
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Exploring Novel Agents to Target Pathways in Lymphoma
August 9th 2018Julie M. Vose, MD, MBA, Chief in the Division of Oncology/Hematology at the University of Nebraska Medical Center, discusses strategies for overcoming resistance in lymphoma during the 2018 Pan Pacific Lymphoma Conference.
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PET-Guided De-escalation a Safe, Effective Approach in Advanced Hodgkin Lymphoma
June 22nd 2018In patients with untreated advanced-stage classical Hodgkin lymphoma, PET can be safely used to guide treatment after 2 cycles of upfront de-escalated BEACOPP, according to the final analysis of the phase III LYSA study presented at the 2018 European Hematology Association Congress.
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Pembrolizumab Approved by FDA for Relapsed/Refractory PMBCL
June 13th 2018Pembrolizumab (Keytruda) has been granted an accelerated approval by the FDA for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or those who have relapsed after 2 or more prior lines of therapy. The approval is based on results from 53 patients with relapsed/refractory PMBCL enrolled in the multicenter, open-label, single-arm KEYNOTE‑170 trial.
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Ibrutinib/Buparlisib Induces Responses in Half of NHL Cohort
June 8th 2018An objective response rate was achieved in 18 of 37 patients with relapsed/refractory non-Hodgkin lymphoma who received the combination of the BTK inhibitor ibrutinib with the PI3K inhibitor buparlisib, according to findings of a phase I/II trial reported at the 2018 ASCO Annual Meeting.
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Oncology Experts Reflect on Key Takeaways from Data Presented at ASCO Annual Meeting
June 7th 2018The 2018 ASCO Annual Meeting was a great success, with over 40,000 people in attendance and over 5000 abstracts presented from June 1-5 in Chicago, Illinois. Data from several phase III trials in lung cancer were presented, with especially significant results in non–small cell lung cancer. Other big areas during this year’s meeting included breast, gastrointestinal, genitourinary, and hematologic cancers.
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Rituximab Plus Lenalidomide Shows Promise in First-Line Setting for Follicular Lymphoma
June 4th 2018Based on data reported at the 2018 ASCO Annual Meeting, the primary endpoint of the phase III RELEVANCE trial was not met with the combination of rituximab plus lenalidomide showing similar efficacy results compared with rituximab plus chemotherapy in treatment-naive patients with follicular lymphoma. The chemotherapy-free regimen, however, did show a more favorable toxicity profile.
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Tisagenlecleucel Granted FDA Approval for Large B-Cell Lymphoma
May 2nd 2018Based on data from the phase II JULIET study, tisagenlecleucel has received FDA approval for the treatment of adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.
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A Look Back at FDA News in the Month of April
May 1st 2018The FDA approved several indications throughout the month of April 2018. A number of drugs were granted priority review and Fast Track designation. The FDA also halted all clinical trials using tazemetostat as treatment, and new initiatives were introduced to help ease the development of genetic and genomic-based tests. Check out our list of all FDA happenings from April 2018.
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Voxtalisib Shows Promising Activity in Follicular Lymphoma
April 24th 2018Voxtalisib (XL765) monotherapy induced objective responses in 41.3% of patients with follicular lymphoma, but displayed minimal efficacy in patients with other lymphomas, according to results from a phase II trial of patients with relapsed or refractory lymphoma or chronic lymphocytic leukemia that were recently published in the Lancet Haematology.
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A Chemotherapy-Free Option for Advanced Follicular Lymphoma
April 21st 2018The combination of CC-122, an investigational pleiotropic pathway modulator, and the second-generation anti-CD20 antibody obinutuzumab induced strong responses in patients with relapsed or refractory follicular lymphoma.
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Duvelisib Granted Priority Review by FDA for CLL and Follicular Lymphoma
April 9th 2018A new drug application seeking a full approval for duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma has been granted a priority review by the FDA.
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A Look Back at FDA News in the Month of March
April 3rd 2018Several new indications were approved by the FDA in March, including blinatumomab (Blincyto) for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here’s a look back on the FDA happenings for the month of March 2018.
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