Mantle Cell Lymphoma News and Research

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$IMBRUVICA-rituximab combination well tolerated in patients with relapsed or refractory MCL$

IMBRUVICA-rituximab combination well tolerated in patients with relapsed or refractory MCL

New IMBRUVICA (ibrutinib) Phase II data announced by Pharmacyclics, Inc. today demonstrates its potential utility as a combination therapy when used with rituximab. Data suggest that the overall efficacy and safety profile of IMBRUVICA is well tolerated when combined with rituximab in patients with relapsed or refractory mantle cell lymphoma (MCL).

9 Dec 2014

Phase 2 RESONATE-17 study: IMBRUVICA (ibrutinib) improves survival in CLL patients with del 17p

Results from the Phase 2 RESONATE-17 (PCYC-1117) study show IMBRUVICA (ibrutinib) was associated with an 82.6 percent investigator-assessed overall response rate (ORR; the primary endpoint) and a 79 percent progression-free survival (PFS) rate at 12 months in people living with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have a genetic mutation known as deletion 17p (del 17p).

9 Dec 2014

IMBRUVICA demonstrates anti-tumor activity against multiple myeloma in Phase II study

New IMBRUVICA (ibrutinib) Phase II data announced here today by Pharmacyclics, Inc) during the 56th American Society of Hematology Annual Meeting suggests that IMBRUVICA demonstrates anti-tumor activity both as a single-agent and as combination therapy in heavily pre-treated patients with relapsed or relapsed/refractory multiple myeloma (MM).

7 Dec 2014

Pharmacyclics launches informCLL registry to explore natural history of CLL patients

Pharmacyclics, Inc. today announced the launch of informCLL, a large, observational, prospective registry that will explore the natural history of chronic lymphocytic leukemia (CLL), examine how IMBRUVICA (ibrutinib) and other approved targeted therapies are being used to treat patients with CLL, and provide a comparison to treatments using conventional chemoimmunotherapy (CIT).

5 Dec 2014

Pharmacyclics wins 2014 Society for Medicines Research Award for Drug Discovery

Pharmacyclics, Inc. today announced that it has won the prestigious 2014 Society for Medicines Research Award for Drug Discovery for its discovery of ibrutinib (IMBRUVICA). The award was presented by The Society of Medicines Research at its biennial award lecture in Kensington, London.

4 Dec 2014

Novartis to highlight advances in blood, breast cancer research at ASH and SABCS 2014

Novartis will highlight more than 250 abstracts demonstrating advances in blood and breast cancer research at the upcoming American Society of Hematology (ASH) annual meeting December 6-9, and CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) December 9-13.

2 Dec 2014

EMA accepts new IMBRUVICA (ibrutinib) application for treatment of Waldenstrom's macroglobulinemia

Pharmacyclics, Inc.today announced the acceptance of a Type II variation application for IMBRUVICA (ibrutinib) by the European Medicines Agency.

1 Dec 2014

Plymouth professor awarded grant to find effective treatment for patients with mantle cell lymphoma

Professor Simon Rule, Professor in Haematology at Plymouth University Peninsula Schools of Medicine and Dentistry and Consultant Haematologist at Plymouth Hospitals NHS Trust, has been awarded a significant grant by Cancer Research UK to carry out a research study into the treatment of older patients with mantle cell lymphoma.

27 Nov 2014

AstraZeneca, Pharmacyclics partner to evaluate efficacy of IMBRUVICA for solid tumors

AstraZeneca and Pharmacyclics, Inc. today announced that they have entered into a clinical trial collaboration to evaluate a novel combination therapy targeting solid tumors.

4 Nov 2014

Janssen announces submission of IMBRUVICA sNDA to FDA for WM treatment

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

20 Oct 2014

Johnson & Johnson's sales increase 5.1% to $18.5 billion in Q3 2014

Johnson & Johnson today announced sales of $18.5 billion for the third quarter of 2014, an increase of 5.1% as compared to the third quarter of 2013. Operational results increased 5.8% and the negative impact of currency was 0.7%. Domestic sales increased 11.6%. International sales decreased 0.3%, reflecting operational growth of 1.0% and a negative currency impact of 1.3%.

14 Oct 2014

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