The addition of ibrutinib (Imbruvica) to bendamustine plus rituximab (Rituxan; BR) or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) did not lead to a statistically significant improvement in progression-free survival (PFS) vs either chemoimmunotherapy regimen alone in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma (MZL), according to findings from the phase 3 SELENE trial (NCT01974440) presented at the 17th Annual International Conference on Malignant Lymphoma.1
The combination of lurbinectedin (Zepzelca) and doxorubicin produced comparable efficacy to that of standard-of-care (SOC) vincristine, cyclophosphamide, and doxorubicin (CAV) or topotecan in patients with relapsed small cell lung cancer (SCLC), missing the primary end point of the phase 3 ATLANTIS trial (NCT02566993).1 However, the doublet did showcase a superior safety and tolerability profile.
Teva will begin producing chemo drug vincristine in the U.S. but has resisted the idea that its withdrawal from the market led to a shortage.
Pfizer is playing a new role in the dramas that often surround drug shortages. While manufacturing issues at its Hospira unit have sometimes been responsible for hospital drug shortages, Pfizer is now trying to fill a serious shortfall after Teva Pharmaceutical discontinued production of a chemo drug used to cure children of serious cancers.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products in China, U.S., and throughout the world, announces the product launch of EVOMELA® (melphalan for injection) in China which is the first commercial product for the Company.
Spectrum Pharmaceuticals sells marketed drugs to Aurobindo subsidiary for up to $300M
BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that 31 abstracts featuring data from the broad ADCETRIS (brentuximab vedotin) development program have been accepted for presentation at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition taking place from December 1-4, 2018 in San Diego, Calif. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of Hodgkin lymphoma (HL) cells and several types of non-Hodgkin lymphoma. ADCETRIS is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials.
SILVER SPRING, Md. & JERUSALEM--(BUSINESS WIRE)--Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody (mAb) biosimilar to Rituxan®1 (rituximab) for the treatment of adult patients in three proposed indications. The proposed indications are: (1) relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) as a single agent; (2) previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and (3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.
AbbVie and Johnson & Johnson’s Imbruvica has failed to meet its key target in a late stage study assessing its use in patients with treatment-naïve diffuse large B-cell lymphoma.
AbbVie updated its Phase III trial of Imbruvica (ibrutinib) in untreated diffuse large B-cell lymphoma (DLBCL), an aggressive type of non-Hodgkin lymphoma (NHL). The trial, DBL3001, studied the addition of Imbruvica to a chemotherapy regimen of five different drugs used in combination—rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP and a placebo. It was conducted in a subset of untreated DLBCL patients that have the non-germinal center B cell (GCB) or activated B-cell (ABC) subtypes. These patients usually have poorer outcomes.