Trials of atezolizumab placed on partial hold

Atezolizumab (Tecentriq)
Photo from Genentech
Roche has announced a partial clinical hold on 2 trials of the anti-PD-L1 antibody atezolizumab (Tecentriq). One is a phase 1b/2 study (NCT02631577) in which researchers are evaluating atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma. The other is a phase 1b study (NCT02431208) of atezolizumab alone or in combination with an immunomodulatory drug and/or daratumumab in patients with multiple myeloma (MM). [Read Article]

EMA issues final opinion on FVIII products

Antihemophilic factor
The European Medicines Agency (EMA) has concluded there is “no clear and consistent evidence” of a difference in inhibitor development between the 2 classes of factor VIII (FVIII) products. A review of data from several studies has suggested that hemophilia A patients are no more likely to develop inhibitors if they receive a recombinant FVIII product rather than a plasma-derived FVIII product. The review began after publication of the SIPPET study, which suggested that patients who received plasma-derived FVIII had a lower incidence of inhibitors than patients treated with recombinant FVIII. [Read Article]

CHMP recommends approval of generic imatinib

Imatinib tablet cut
with a pill splitter
Photo by Patrick Pelletier
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for Imatinib Teva B.V., a generic of Glivec. The recommendation is that Imatinib Teva B.V. be approved to treat chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), hypereosinophilic syndrome (HES), chronic eosinophilic leukemia (CEL), myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPNs), gastrointestinal stromal tumors (GIST), and dermatofibrosarcoma protuberans (DFSP). [Read Article]