Lymphoma (includes NHL, HL, CNS Lymphoma)

UK Rejects Adult Novartis CAR-T Therapy, After 'Yes' in Kids

(Reuters) Sept 19, 2018 - Health authorities in England have rejected a pricey CAR-T cell therapy from Novartis for adults with blood cancer, two weeks after endorsing its use in children and young people. The National Institute for Health and Care Excellence (NICE) said Kymriah was not cost-effective for adult lymphoma. That contrasts with a green light for youngsters with aggressive leukaemia when other drugs have failed.

read article

Cancer Coaches Help Guide Patients During and After Treatment

(Wall Street Journal) Sept 16, 2018 - Tom Loeswick has faced a series of illnesses in his life, but when he was diagnosed with stage 3 lymphoma in 2012 at the age of 61, he felt helpless, emotionally drained and disconnected.

read article (paid subscription required)

Clinical Trial Shows Best Outcomes to Date for Older Hodgkin Lymphoma Patients

(Rutgers/CINJ) Sept 4, 2018 - Recently published results of a phase 2 clinical trial have shown the best outcomes to date for newly diagnosed older Hodgkin lymphoma patients treated with brentuximab vedotin given before and after doxorubicin, vinblastine and dacarbazine (AVD) chemotherapy, which is the standard of care.

read press release

Verastem Oncology Announces Investigator Sponsored Study on Duvelisib in Combination with Venetoclax

(MarketWatch) Sept 6, 2018 - Phase I/II trial to investigate combination therapy in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma to take place at Dana-Farber Cancer Institute.

read article

OPKO Health’s BioReference Laboratories to Participate in the National Cancer Institute NCI-MATCH (Molecular Analysis for Therapy Choice) Phase II Clinical Trial

(NASDAQ) Aug 28, 2018 - OPKO Health, Inc. today announced that BioReference Laboratories, Inc. (BRL), an OPKO Health company and the third largest clinical laboratory in the United States, has signed a collaboration agreement with the National Cancer Institute (NCI) and ECOG-ACRIN Cancer Research Group (ECOG-ACRIN).

read article

AbbVie Announces IMBRUVICA® (ibrutinib) Plus Rituximab Approval by U.S. FDA as First Chemotherapy-Free Combination Treatment in Adults with Waldenström's Macroglobulinemia, a Rare Type of Blood Cancer

(Markets Insider) Aug 27, 2018 - AbbVie, a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) plus rituximab (RITUXAN®) for the treatment of adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). With this approval, the IMBRUVICA prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. IMBRUVICA was first approved as a single agent therapy for WM in January 2015. IMBRUVICA is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

read article

FDA Approves Drug Duo for Waldenstrom's Macroglobulinemia

(CureToday.com) Aug 27, 2018 - The FDA has approved Imbruvica (ibrutinib) for use in combination with Rituxan (rituximab) as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia. The approval is based on findings from the phase 3 iNNOVATE (PCYC-1127) trial presented at the 2018 ASCO Annual Meeting and published in the New England Journal of Medicine. In the study the Imbruvica/Rituxan combination lowered the risk of disease progression or death by 80 percent versus Rituxan alone in patients with Waldenström macroglobulinemia. At a median follow-up of 26.5 months, the median progression-free survival (PFS) was not reached with the Imbruvica combination and was 20.3 months with Rituxan alone. The 30-months PFS rates were 82 percent versus 28 percent, respectively.

read article

Novartis Receives European Commission Approval of Its CAR-T Cell Therapy, Kymriah® (tisagenlecleucel)

(Novartis) Aug 27, 2018 - The EC approval is based on the first global CAR-T registration trials, which included patients from eight European countries and demonstrated durable responses and a consistent safety profile in r/r pediatric B-cell ALL and r/r DLBCL.

read corporate press release

Yescarta® (Axicabtagene Ciloleucel) Receives European Marketing Authorization for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy

(Gilead) Aug 27, 2018 - Kite, a Gilead Company, today announced that the European Commission (EC) has granted Marketing Authorization for Yescarta® (axicabtagene ciloleucel) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.

read corporate press release

Experimental Drug Takes Aim At Cancers Associated With Epstein-Barr Virus

(American Society for Microbiology) Aug 22, 2018 - Epstein-Barr Virus (EBV) doesn't directly cause cancer, but infection with this common herpes virus brings an increased risk of some cancers, including fast-growing lymphomas. This week in mSphere, researchers report on a new drug that works by targeting EBV-positive tumors.

read press release

'Liquid Biopsy' Predicts Lymphoma Therapy Success Within Days

(Stanford Medicine) Aug 20, 2018 - Changes in circulating tumor DNA levels quickly predict how patients with diffuse large B cell lymphoma are responding to therapy, according to a Stanford-led study. Currently, patients wait months for the results.

read press release

Disparities in Follicular Lymphoma Survival Associated With Age, Insurance Status

(Journal Of Clinical Pathways) Aug 14, 2018 - Patients with follicular lymphoma and private health insurance have nearly 2-fold better survival outcomes compared with patients without insurance or those covered by Medicare or Medicaid, according to a study published in Blood.

read article

Sutro and The Leukemia & Lymphoma Society Partner on Lymphoma and Multiple Myeloma Treatment

(Markets Insider) Aug 13, 2018 - Sutro Biopharma, Inc., and The Leukemia & Lymphoma Society® , or LLS, are partnering to develop STRO-001, Sutro's CD74-targeting antibody-drug conjugate, to treat relapsed and/or refractory multiple myeloma and non-Hodgkin's lymphoma.

read article

Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome

(Markets Insider) Aug 8, 2018 – Kyowa Hakko Kirin Co., Ltd., announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Poteligeo® (mogamulizumab- kpkc) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. FDA granted Priority Review and Breakthrough Therapy Designation in late 2017. Poteligeo is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain blood cancers including CTCL. Using the proprietary POTELLIGENT® technology, the amount of fucose in the sugar chain structure of Poteligeo is reduced, which enhances the antibody dependent cellular cytotoxicity (ADCC). “I believe the approval is very good news for patients who have been suffering from mycosis fungoides (MF) or Sézary syndrome (SS) in the US,” said Mitsuo Satoh Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin. "Since this antibody was discovered through our cutting- edge R&D activity, it is also another important achievement for Kyowa Hakko Kirin in leaping forward to become a global specialty pharmaceutical company.”

read article

FDA Approves Mogamulizumab-kpkc for Mycosis Fungoides or Sézary Syndrome

(ASCO in Action) Aug 8, 2018 - On Aug. 8, 2018, the Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo, Kyowa Kirin, Inc.) for adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. The approval of mogamulizumab-kpkc, a CC chemokine receptor type 4 (CCR4) directed monoclonal antibody, was based on a randomized, open-label, multicenter trial (Study 0761-010; NCT01728805) in patients with active MF or SS after at least one prior systemic therapy. Patients enrolled had a median of 3 prior therapies. The trial randomized 372 patients (44% with SS) to either mogamulizumab-kpkc or vorinostat. Progression-free survival (PFS) was statistically significantly longer in the mogamulizumab-kpkc arm. The estimated median PFS was 7.6 months (95% CI: 5.6, 10.2) for those treated with mogamulizumab-kpkc compared with 3.1 months (95% CI: 2.8, 4.0) in the vorinostat arm (hazard ratio 0.53; 95% CI: 0.41, 0.69). The confirmed overall response rate was 28% and 5%, respectively (p<0.001).

read article

FDA Approves Treatment For Two Rare Types Of Non-Hodgkin Lymphoma

(FDA.gov) Aug 8, 2018 - The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS. “Mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin lymphoma and this approval fills an unmet medical need for these patients,” 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. “We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients.”

read press release

ADC Therapeutics Doses First Patient in Pivotal Clinical Trial of ADCT-402 in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

(Morningstar) Aug 7, 2018 - ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), today announced that the first patient has been dosed in its Phase II clinical trial intended to support the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

read article

Epizyme Halts Phase II Trial of Tazemetostat in DLBCL, Continues Talks to Lift Clinical Hold

(Genetic Engineering & Biotechnology News) Aug 2, 2018 - Epizyme said today it will halt a Phase II clinical trial assessing its lead candidate, the cancer treatment tazemetostat in relapsed and/or refractory diffuse large B-cell lymphoma (r/r DLBCL). The trial halt comes more than three months after the FDA imposed a partial clinical hold on tazemetostat stemming from a separate trial—a hold that the company said it is working to have lifted. The company said it will end its Phase II trial evaluating tazemetostat as monotherapy in cohorts of patients with r/r DLBCL (NCT01897571). The cohorts include DLBCL patients who have received tazemetostat in combination with prednisolone; as well as cohorts of DLBCL patients with EZH2 activating mutations, and with wild-type EZH2 who have been receiving tazemetostat as monotherapy.

read article

NICE Backing For Keytruda In Classical Hodgkin Lymphoma

(PharmaTimes [UK]) July 26, 2018 - The National Institute for Health and Care Excellence has recommended that MSD’s Keytruda be funded on the NHS via the Cancer Drugs Fund (CDF) for a subgroup of people with relapsed or refractory classical Hodgkin lymphoma.

read article

Celgene Announces Phase III ‘AUGMENT' Study of REVLIMID® in Combination with Rituximab (R²) for the Treatment of Patients with Relapsed/Refractory Indolent Lymphoma Met Primary Endpoint

(Celgene) July 23, 2018 - Celgene Corporation today announced results from a phase III, randomized, double-blind, international clinical study (AUGMENT). REVLIMID® (lenalidomide) plus rituximab (R2) achieved a highly statistically significant improvement in the primary endpoint of progression-free survival (PFS), compared to rituximab plus placebo, in the final PFS analysis. AUGMENT evaluated the efficacy and safety of the investigational combination of R2 versus rituximab plus placebo in patients (N=358) with relapsed/refractory follicular and marginal zone lymphoma. In addition to achieving the primary endpoint of the study, a favorable trend was observed for overall survival (OS) during this analysis and follow-up will continue for the mature OS results. The safety profile of R2 was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.

read corporate press release
Next Page