5 Most Recent FDA Approvals Patients With Cancer May Have Missed


The Food and Drug Administration has had a busy couple of weeks, approving new agents to treat a variety of cancers. Here are five recent approvals that patients with cancer may have missed.

As spring turns to summer, the Food and Drug Administration (FDA) is not slowing down in approving drugs in the oncology space — some for very specific cancer types, and others (such as the recent approval of Keytruda) for a whole range of solid tumors that have a high mutational burden.

In case you missed it, CURE® compiled a list of the five most recent FDA approvals.

Xpovio For Patients with Relapsed or Refractory DLBCL

The approval is for patients with this subtype of non-Hodgkin lymphoma who have had two or more prior therapies. READ MORE.

Tazverik for Certain Patients With Relapsed/Refractory Follicular Lymphoma

The agency gave accelerated approval to the treatment based on data from a phase 2 clinical trial that showed that patients with EZH2-mutant disease achieved an objective response rate (ORR) — the percentage of complete and partial responses to treatment – of 69% and patients with wild-type EZH2 follicular lymphoma achieved an ORR of 35%. READ MORE.

Keytruda to Treat Tumor Mutational Burden-High Solid Tumors

The FDA granted accelerated approval to Keytruda (pembrolizumab) for this indication based on tumor response rate and durability of response from a prospectively-planned retrospective analysis of 10 cohorts of patients with various previously treated unresectable or metastatic solid tumors with TMB-H that were enrolled in the multicenter, non-randomized, open-label KEYNOTE-158 trial. READ MORE.

Mylotarg for Children With Newly-Diagnosed CD33-Positive AML. The FDA extended the indication of Mylotarg (gemtuzumab ozogamicin) to include the treatment of children aged one month or older with newly diagnosed CD33-positive acute myeloid leukemia (AML). READ MORE.

Zepzelca for Metastatic Small Cell Lung Cancer. The approval is for patients with small cell lung cancer whose disease progressed after a platinum-based chemotherapy. READ MORE.

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