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FDA Approves Calquence (acalabrutinib) for Adults with Mantle Cell Lymphoma

Posted 17 days ago by Drugs.com

October 31, 2017 – The U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies.” Mantle cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma and, according to the National Cancer Institute at the National Institutes of Health, represents 3 to 10 percent of all non-Hodgkin lymphoma cases in t ... Read more

Related support groups: Lymphoma, Mantle Cell Lymphoma, Calquence, Acalabrutinib

Calquence Approved for Mantle Cell Lymphoma

Posted 17 days ago by Drugs.com

TUESDAY, Oct. 31, 2017 – Calquence (acalabrutinib) has been approved by the U.S. Food and Drug Administration to treat adults with mantle cell lymphoma. Mantle cell is an aggressive, fast-growing non-Hodgkin lymphoma, a cancer of the lymph system. Though it represents only 3 percent to 10 percent of non-Hodgkin cases in the United States, the cancer usually has spread by the time it's detected, the FDA said in a news release on Tuesday. "For patients who have not responded to treatment or who have relapsed, Calquence provides a new treatment option that has shown high rates or response for some patients in initial studies," said Dr. Richard Pazdur, director of the agency's Oncology Center of Excellence. Calquence is a kinase inhibitor that's designed to block an enzyme that cancer cells use to multiply, the FDA said. The drug was evaluated in a clinical study of 124 people with mantle ... Read more

Related support groups: Cancer, Lymphoma, Mantle Cell Lymphoma

Calquence Approved for Mantle Cell Lymphoma

Posted 17 days ago by Drugs.com

TUESDAY, Oct. 31, 2017 – Calquence (acalabrutinib) has been approved by the U.S. Food and Drug Administration to treat adults with mantle cell lymphoma. Mantle cell is an aggressive, fast-growing non-Hodgkin lymphoma, a cancer of the lymph system. Though it represents only 3 percent to 10 percent of non-Hodgkin cases in the United States, the cancer usually has spread by the time it's detected, the FDA said in a news release on Tuesday. "For patients who have not responded to treatment or who have relapsed, Calquence provides a new treatment option that has shown high rates or response for some patients in initial studies," said Dr. Richard Pazdur, director of the agency's Oncology Center of Excellence. Calquence is a kinase inhibitor that's designed to block an enzyme that cancer cells use to multiply, the FDA said. The drug was evaluated in a clinical study of 124 people with mantle ... Read more

Related support groups: Cancer, Lymphoma, Mantle Cell Lymphoma

Textured Breast Implants Linked to Rare Cancer

Posted 20 Oct 2017 by Drugs.com

FRIDAY, Oct. 20, 2017 – A particular breast implant may be associated with a rare type of cancer, researchers report. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is estimated to affect 1 in 30,000 women each year, but researchers said it may actually be more common. "We're seeing that this cancer is likely very underreported, and as more information on this type of cancer comes to light, the number of cases is likely to increase in the coming years," said Dr. Dino Ravnic. He is an assistant professor of surgery at Penn State College of Medicine. Penn State investigators reviewed 115 research reports in which 95 patients were evaluated to learn more about risk, development and treatment of BIA-ALCL. Nearly all cases were associated with textured breast implants, which have a slightly rough surface to keep them in the correct position. "We're still exploring the ... Read more

Related support groups: Surgery, Breast Cancer, Lymphoma, Breast Cancer - Adjuvant, Breast Cancer, Prevention

FDA Approves Yescarta (axicabtagene ciloleucel) CAR-T Cell Therapy to Treat Adults with Certain Types of Large B-Cell Lymphoma

Posted 19 Oct 2017 by Drugs.com

October 18, 2017 – The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL). “Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” said FDA Commissioner Scott Gottlieb, M.D. “This approval demonstrates the continued momentum of this promising new area of medicine and we’re committed to ... Read more

Related support groups: Lymphoma, Non-Hodgkin's Lymphoma, Yescarta, Diffuse Large B-Cell Lymphoma, Axicabtagene Ciloleucel

Newer Drug May Prolong Lymphoma Remission

Posted 5 Oct 2017 by Drugs.com

WEDNESDAY, Oct. 4, 2017 – A newer drug may beat the standard treatment when it comes to battling the blood cancer follicular lymphoma, a clinical trial suggests. Follicular lymphoma is one type of non-Hodgkin lymphoma, a group of cancers that arise in white blood cells. The new study found that a drug called obinutuzumab (Gazyva) typically kept the cancer under control longer, versus the standard drug rituximab (Rituxan). After three years, about 80 percent of obinutuzumab patients were showing no signs of cancer progression or relapse. That compared with roughly 73 percent of rituximab patients, according to the report. Cancer experts said the results, published in the Oct. 5 issue of the New England Journal of Medicine, are a positive step forward. But they do not necessarily mean obinutuzumab is the better choice for all patients, according to Dr. James Armitage, an oncologist at ... Read more

Related support groups: Lymphoma, Follicular Lymphoma, Obinutuzumab, Gazyva

Adding Rituximab to Standard Care May Prolong Lymphoma Survival

Posted 28 Sep 2017 by Drugs.com

WEDNESDAY, Sept. 27, 2017 – Long-term treatment with the drug rituximab (Rituxan) may extend the lives of some patients with a rare form of blood cancer, a new clinical trial finds. The disease, known as mantle-cell lymphoma, is generally incurable. But various treatments can prolong people's lives. Some patients, for instance, are able to undergo chemotherapy to wipe out the cancer cells, followed by a stem cell transplant – to restore normal blood cells. But while that approach can be effective for a while, most patients see the cancer come back. So the new trial, funded by Rituxan maker Roche, looked at whether an additional step could help: Having patients take Rituxan for three years following their stem cell transplant. Overall, researchers found, the tactic did improve patients' outlook. After four years, 83 percent of rituximab patients were still alive and progression-free – ... Read more

Related support groups: Rituxan, Lymphoma, Rituximab, Mantle Cell Lymphoma, Rituxan Hycela, Hyaluronidase/rituximab

FDA Approves Aliqopa (copanlisib) for Adults with Relapsed Follicular Lymphoma

Posted 17 Sep 2017 by Drugs.com

September 14, 2017 – The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them.” Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma, a cancer of the lymph system. The lymph system is part of the body’s immune system and is made up of lymph tissue, lymph ... Read more

Related support groups: Lymphoma, Follicular Lymphoma, Aliqopa, Copanlisib

Aliqopa Approved for Follicular Lymphoma

Posted 14 Sep 2017 by Drugs.com

THURSDAY, Sept. 14, 2017 – Aliqopa (copanlisib) has been approved by the U.S. Food and Drug Administration to treat adults with relapsed follicular lymphoma who have received at least two prior treatments with certain other drugs. Follicular lymphoma is a slow-growing cancer of the lymph system of the type known as non-Hodgkin lymphoma. More than 72,000 people in the United States are likely to be diagnosed with some form of the illness this year, and more than 20,000 will die from the disease, federal estimates project. Aliqopa is among a class of drugs called kinase inhibitors that are designed to block enzymes that spur cancer growth, the FDA explained Thursday in a news release. The drug was given accelerated approval based on a 104-person clinical study, which found 59 percent of users had complete or partial response after an average of 12 months. As a condition of approval, the ... Read more

Related support groups: Lymphoma, Follicular Lymphoma, Aliqopa, Copanlisib

FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas

Posted 6 Jul 2017 by Drugs.com

June 29, 2017 – The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN). “This represents a major step forward for the hematology-oncology community,” said Alberto Gutierrez, Ph.D., Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Laboratories and health care professionals now have access to an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers.” According to the National Cancer Institute, leukemia is a cancer of the blood that originates in immatu ... Read more

Related support groups: Leukemia, Lymphoma, Diagnosis and Investigation

FDA Approves Rituxan Hycela (rituximab and hyaluronidase human) for Subcutaneous Injection in Certain Blood Cancers

Posted 26 Jun 2017 by Drugs.com

South San Francisco, CA – June 22, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous (under the skin) injection for the treatment of adults with the following blood cancers: previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously treated chronic lymphocytic leukemia (CLL). This new treatment includes the same monoclonal antibody as intravenous Rituxan® (rituximab) in combination with hyaluronidase human, an enzyme that helps to deliver rituximab under the skin. “With today’s approval of Rituxan Hycela, people with three of the most common blood cancers now have a new treatment option which provides efficacy c ... Read more

Related support groups: Cancer, Leukemia, Rituxan, Lymphoma, Chronic Lymphocytic Leukemia (CLL), Rituximab, Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, Rituxan Hycela, Hyaluronidase/rituximab

FDA Medwatch Alert: Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Posted 21 Mar 2017 by Drugs.com

ISSUE: FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces. BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data. See the FDA Update for additional information, including a summary of Medical Device Reports and medical literature, and r ... Read more

Related support groups: Lymphoma

FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL)

Posted 15 Mar 2017 by Drugs.com

KENILWORTH, N.J. March 14, 2017 --(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In refractory or relapsed cHL, Keytruda is approved for use in adult patients at a fixed dose of 200 mg and in pediatric patients at a dose of 2 mg/kg (up to a maximum of 200 ... Read more

Related support groups: Lymphoma, Keytruda, Hodgkin's Lymphoma, Pembrolizumab

Gene Therapy Shows Promise for Aggressive Lymphoma

Posted 28 Feb 2017 by Drugs.com

TUESDAY, Feb. 28, 2017 – An experimental gene therapy for aggressive non-Hodgkin lymphoma beat back more than a third of cancers that seemed untreatable, the therapy's developers report. Thirty-six percent of over 100 very ill lymphoma patients appeared disease-free six months after a single treatment, according to results released by the treatment's maker, Kite Pharma of Santa Monica, Calif. These patients had not responded to usual treatments and had no other options, Kite said Tuesday in a news release. Overall, more than four out of five patients with the blood cancer saw their cancer reduced by more than half for at least part of the study, the company said. "This seems extraordinary ... extremely encouraging," one cancer specialist, Dr. Roy Herbst, told the Associated Press. But Herbst, who is chief of medical oncology at Yale Cancer Center in New Haven, Conn., said longer ... Read more

Related support groups: Cancer, Lymphoma, Non-Hodgkin's Lymphoma

U.S. FDA Approves Imbruvica (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL)

Posted 25 Jan 2017 by Drugs.com

NORTH CHICAGO, Ill., Jan. 19, 2017 /PRNewswire/ – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) approved Imbruvica (ibrutinib) for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.1 This indication is approved under accelerated approval based on overall response rate (ORR), and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. Imbruvica is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc. "The FDA approval of Imbruvica for relapsed/refractory marginal zone lymphoma is significant, and we are proud of the culmination of this extensive clinical research program, representing ... Read more

Related support groups: Lymphoma, Imbruvica, Ibrutinib

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