The FDA has granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro®, Janssen Biotech, Inc.) in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of patients with newly diagnosed amyloid light chain (AL) amyloidosis. "As immunoglobulin light chains present in AL amyloidosis are considered to be toxic to involved organs, especially the heart, rapid and deep hematologic remission with reduction of these light chains with frontline ther ..read more

Crizotinib (Xalkori®, Pfizer) is now FDA approved for the treatment of pediatric patients age one year and older and young adult patients with relapsed/refractory systemic ALK-positive anaplastic large cell lymphoma (ALCL). The approval was based on Study ADVL0912 (NCT00939770), a single-arm phase 1/2 trial. "Various human cancers have ALK gene translocations, amplifications, or oncogenic mutations, such as ALCL, inflammatory myofibroblastic tumors, non-small cell lung cancer (NSCLC), and neurob ..read more

In patients with treatment-naive or relapsed/refractory chronic lymphocytic leukemia (CLL), the combination of umbralisib and ublituximab significantly increases progression-free survival (PFS) compared with obinutuzumab/chlorambucil, according to results of a phase 3 trial recently presented at the American Society of Hematology (ASH) Annual Meeting. "Umbralisib is an oral, once-daily, novel dual inhibitor of phosphatidylinositol-3-kinase-delta (PI3Kδ) and casein kinase-1ε (CK1ε) that exhibits ..read more

The oral hypomethylating agent CC-486, when administered in an escalated dosing schedule (>7 days per 28-day treatment cycle), has been shown to be effective and well tolerated for patients with acute myeloid leukemia (AML) experiencing their first relapse, according to results of a study presented at American Society of Hematology (ASH) Annual Meeting. For the phase 3 international, randomized, double-blind QUAZAR AML-001 trial (NCT01757535), 472 patients with AML were enrolled. To be eligib ..read more

Among patients with relapsed/refractory acute lymphoblastic leukemia (ALL), those with Philadelphia chromosome (Ph)-positive disease experience a higher rate of relapse and poorer chances of long-term survival. According to results of the phase 3 INO-VATE trial recently published in Cancer, inotuzumab ozogamicin, a humanized anti-CD22 monoclonal antibody, achieved high rates of response, remission, and progression-free survival in patients with this disease. In this interview with i3 Health, Hag ..read more

In patients with relapsed/refractory Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL), inotuzumab ozogamicin increases rates of response, remission, hematopoietic stem cell transplantation (HSCT), and progression-free survival compared with intensive chemotherapy, although it does not produce a significant improvement in overall survival. "Historically, patients with Ph-positive ALL have had poorer prognoses, with higher rates of relapse and worse long-term survival ..read more

According to the results of a new study, therapeutic combinations containing carfilzomib are safe and effective for frail patients with relapsed/refractory (R/R) multiple myeloma. "Frail patients with multiple myeloma can be challenging to treat, as they are potentially less able to tolerate therapy, are more vulnerable to side effects, and have compromised physiological function," write the study's investigators, led by first author Thierry Facon, MD, Professor of Hematology at Lille University ..read more

Positive survival outcomes were observed in patients with Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL) when treated with dasatinib followed by blinatumomab in in a phase 2 study now published in the New England Journal of Medicine. For the trial, adults with newly diagnosed Ph-positive ALL were given a seven-day prephase treatment with a glucocorticoid prior to the first administration of dasatinib in a 140 mg dose. Glucocorticoids were continued for 24 more days ..read more

PembrolizumabThe FDA has now expanded the approved indications for pembrolizumab (KEYTRUDA®, Merck Sharp & Dohme) to include both adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) and pediatric patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy. The approval was based on efficacy data from the open-label phase 3 KEYNOTE-204 trial (NCT02684292), for which 304 adult patients with cHL previously treated with at least one multiagen ..read more

The FDA has now granted full approval to venetoclax (Venclexta®, AbbVie Inc. and Genentech Inc.) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for patients with previously untreated acute myeloid leukemia (AML) who are at least 75 years of age or who have comorbidities that prevent them from receiving intensive induction chemotherapy. Previously, this venetoclax combination therapy was granted accelerated approval in 2018 for use in this same patient population. The ..read more