Mantle Cell Lymphoma News and Research

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FDA approves use of Imbruvica to treat patients with chronic lymphocytic leukemia

The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use.

29 Jul 2014

EMA CHMP adopts positive opinion for Janssen’s IMBRUVICA to treat CLL and MCL

Janssen-Cilag International NV announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the granting of a marketing authorisation for IMBRUVICA (ibrutinib) in the European Union.

29 Jul 2014

EMA recommends full marketing approval for IMBRUVICA in the European Union

Pharmacyclics, Inc. today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending the granting of full marketing approval for IMBRUVICA (ibrutinib) in the European Union.

25 Jul 2014

Johnson & Johnson sales increase 9.1% to $19.5 billion in second quarter 2014

Johnson & Johnson today announced sales of $19.5 billion for the second quarter of 2014, an increase of 9.1% as compared to the second quarter of 2013. Operational results increased 9.4% and the negative impact of currency was 0.3%.

15 Jul 2014

Janssen seeks expanded approval of VELCADE from EU for Mantle Cell Lymphoma

Janssen-Cilag International NV today announced its submission of a type II variation to the European Medicines Agency to expand the label for VELCADE (bortezomib) to include its use, in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of adult patients with previously untreated Mantle Cell Lymphoma (MCL).

28 Jun 2014

Cancer drug offers protection against thrombosis

Case Western Reserve University researchers have discovered that an existing drug used to help cancer patients has the potential to protect thousands of others from the often-deadly impact of vascular clots.

12 Jun 2014

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

9 Jun 2014

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc.

8 Apr 2014

Patrys provides update on development programme for anti-cancer product, PAT-LM1

Patrys Limited, a clinical stage biotechnology company, is pleased to provide an update on the development programme for anti-cancer product, PAT-LM1.

24 Mar 2014

New drug for patients with leukaemia and lymphoma puts an end to chemotherapy

Patients with terminal forms of leukaemia and lymphoma who have run out of treatment options could soon benefit from a new drug, which not only puts an end to chemotherapy and has virtually no side effects but also improves a patient's life expectancy and quality of life.

20 Mar 2014

A pill may provide hope to relapsed leukemia and lymphoma patients

A pill that suppresses a key regulator of cancer growth may provide hope to relapsed leukemia and lymphoma patients running out of treatment options for their aggressive, treatment-resistant disease, according to three reports published online today in Blood, the journal of the American Society of Hematology.

10 Mar 2014

Pharmacyclics total revenue for fourth quarter 2013 increases 113% to $123.6 million

Pharmacyclics, Inc. today reported financial results and recent developments for the quarter and year ended December 31, 2013.

20 Feb 2014

FDA approves Biologics’ IMBRUVICA as oral agent for treatment of patients with CLL

Biologics, a limited distribution network partner for IMBRUVICA™ (ibrutinib), is pleased to announce the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA™ (ibrutinib) capsules as a single, oral agent for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

14 Feb 2014

Use of twice-daily pill could turn deadly blood cancer into highly treatable disease

Use of a twice-daily pill could turn a deadly blood cancer into a highly treatable disease, according to scientists at Weill Cornell Medical College who led a multinational research team.

24 Jan 2014

IDMC recommends early stopping of Phase 3 study of ibrutinib in treatment of CLL/SLL

Janssen-Cilag International NV today announced the early stopping of PCYC-1112-CA, the Phase 3 study of ibrutinib in the treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, based on the recommendation of an Independent Data Monitoring Committee, which concluded that the study showed a significant difference in progression-free survival as compared to the control, the primary endpoint of the study.

8 Jan 2014

Celgene subsidiary presents REVLIMID study results on lymphoma at ASH annual meeting

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG) today announced that results from two studies of REVLIMID (lenalidomide) combinations in patients with diffuse large B-cell lymphoma (DLBCL) were presented at the American Society of Hematology annual meeting in New Orleans, La.

11 Dec 2013

Pharmacyclics presents ibrutinib trial data for B-cell malignancies at ASH meeting

Pharmacyclics, Inc. today announced results of 40 clinical, non-clinical and pre-clinical presentations on ibrutinib (IMBRUVICA™) at the 55TH Annual meeting of the American Society of Hematology (ASH) held in New Orleans, Dec 7 - 10, 2013.

11 Dec 2013

Acetylon announces positive preclinical data of ricolinostat (ACY-1215) in models of lymphoma

Acetylon Pharmaceuticals, Inc., the leader in the development of selective histone deacetylase (HDAC) inhibitors for enhanced therapeutic outcomes, announced that positive preclinical data of selective HDAC6 inhibitor, ricolinostat (ACY-1215), in models of lymphoma were presented today in an oral presentation by Dr. Jennifer Amengual, Assistant Professor of Medicine & Experimental Therapeutics, Columbia University Medical Center.

10 Dec 2013

CAR therapy shows potential for advancing treatment of patients with ALL and CLL

Novartis is highlighting new research from members of the faculty at the University of Pennsylvania’s Perelman School of Medicine on the investigational chimeric antigen receptor therapy, CTL019. Several studies being presented at the American Society of Hematology annual meeting add to the scientific understanding of CTL019 in the treatment of acute lymphoblastic leukemia and chronic lymphocytic leukemia and build on earlier research findings.

9 Dec 2013

Diplomat selected as provider of IMBRUVICA capsules for MCL treatment

Diplomat, the country's largest independent specialty pharmacy, announced today it is one of five specialty pharmacies selected as a provider of IMBRUVICA (ibrutinib) capsules, approved Nov. 13 by the U.S. Food and Drug Administration for the treatment of Mantle Cell Lymphoma.

16 Nov 2013