Drugs

Calquence Combo OK’d for Leukemia, Lymphoma

FDA has approved AstraZeneca’s Calquence (acalabrutinib) for use in combination with AbbVie and Genentech’s Venclexta (venetoclax), a chemotherapy-free regimen for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), clearing their use as an initial treatment option.

The approval is based on results from the Phase 3 AMPLIFY trial, a randomized, multicenter study evaluating the targeted therapy combination against standard chemoimmunotherapy regimens. The study enrolled patients without del(17p) or TP53 mutations and compared acalabrutinib plus venetoclax (AV) with investigator’s choice of fludarabine, cyclophosphamide and rituximab (FCR) or bendamustine plus rituximab (BR).

After a median progression-free survival (PFS) follow-up of 42.6 months, median PFS was not reached in the AV arm, compared with 47.6 months in the chemotherapy arm, FDA says. The combination reduced the risk of disease progression or death by 35% versus FCR or BR, it adds. With a median overall follow-up of 41 months, 6% of patients in the AV group had died, compared with 14% in the chemotherapy group.

The approval marks another step in a shift toward targeted, time-limited oral regimens in frontline CLL, a disease historically treated with cytotoxic chemotherapy. Acalabrutinib is a Bruton tyrosine kinase (BTK) inhibitor, while venetoclax targets the BCL-2 protein, a key regulator of apoptosis in malignant B cells.

The acalabrutinib label includes warnings for serious and opportunistic infections, hemorrhage, cytopenias, second primary malignancies, cardiac arrhythmias and hepatotoxicity. Venetoclax carries boxed and other warnings for tumor lysis syndrome, neutropenia, infections and embryo-fetal toxicity.

Calquence is currently approved for treating adult patients with previously untreated mantle cell lymphoma.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome