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The FDA approved several drugs throughout November for the treatment of diseases including leukemia and biliary tract cancer, in addition to a diagnostic for solid cancers.
Here's a look at five cancer-related FDA approvals from November 2024.
Several cancer therapies and a companion diagnostic received approval from the Food and Drug Administration (FDA) for diseases including leukemia, biliary tract cancer and other solid tumor types.
Here is a select list of oncology drugs and diagnostics approved by the FDA last month.
Complete remission: the disappearance of all signs of cancer after treatment.
Pharmacokinetics: the activity of drugs in the body over time, which includes how drugs are absorbed in the body, distributed, localized in tissues and excreted.
Objective response rate: patients who responded partially or completely to treatment.
The FDA has granted approval for Aucatzyl (obecabtagene autoleucel), a CAR-T cell therapy, to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-cell ALL). This therapy leverages a patient's own immune cells, genetically engineered to target and destroy cancer cells.
The approval was based on results from the FELIX trial, which demonstrated Aucatzyl's efficacy in patients with relapsed or refractory CD19-positive B-cell ALL. In particular, patients in the trial relapsed after a remission lasting no longer than 12 months, disease that was relapsed or refractory three or more months after allogeneic stem cell transplantation, or relapsed or refractory ALL after two or more lines of systemic therapy.
Of the 65 patients with evaluable information in the FELIX trial, 27 patients — or 42% — achieved complete remission within three months, with a median duration of complete remission within three months of 14.1 months.
Danziten, a formulation of nilotinib, received approval from the FDA for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase and adults with chronic phase and acute phase resistant or intolerant to prior therapy with Gleevec (imatinib).
An advantage of Danziten is that it does not require fasting, unlike other medications for chronic myeloid leukemia. This can significantly improve patient adherence to treatment. Studies have shown that Danziten may be as effective as Tasigna, another formulation of nilotinib, but with improved bioavailability and consistent pharmacokinetics, regardless of whether a patient has eaten or not.
The FDA has approved Revuforj (revumenib) for adults and children with relapsed or refractory acute leukemia with a specific genetic mutation known as a KMT2A translocation.
Revuforj is a first-in-class menin inhibitor that targets a specific protein involved in the development of leukemia cells. Clinical trials have shown promising results, with a significant number of patients achieving complete remission. In particular, of the patients in the AUGMENT-101 trial, 21.2% achieved complete remission plus complete remission with partial hematological recovery with a median duration of 6.4 months. In addition, of the 22 patients who achieved either complete response or complete remission with partial hematological recovery, the median time to either of those outcomes was 1.9 months.
The most common side effects, which occurred in at least 20% of patients, included nausea, bleeding, musculoskeletal pain, high phosphate levels, increased aspartate aminotransferase and infection, among others.
The FDA has approved a new companion diagnostic tool called MI Cancer Seek for adults and children with cancer. This test can identify patients who may benefit from targeted therapies for several different cancers including breast, colorectal, melanoma, solid tumors, endometrial carcinoma and non-small cell lung cancer.
MI Cancer Seek works by combining whole exome and transcriptome sequencing, which reduces the need for separate DNA and RNA tests. This saves both tissue and time, while still providing accurate results to guide treatment decisions.
The FDA has approved Ziihera (zanidatamab-hrii) for adults with biliary tract cancer that has progressed after prior treatment and has an EGFR exon 20 insertion genetic mutation.
Ziihera, the first dual HER2-targeted bispecific antibody approved for this patient population in the United States, received accelerated approval based on a 52% objective response rate (ORR) and a median duration of response of 14.9 months in the HERIZON-BTC-01 clinical trial, according to a news release from manufacturer Jazz Pharmaceuticals.
The drug comes with a Boxed Warning for embryo-fetal toxicity, noting that exposure to the drug during pregnancy can cause embryo-fetal harm. The safety profile of Ziihera was demonstrated among 80 patients in HERIZON-BTC-01, with serious side effects occurring in 53% of patients. The most common side effects occurring in at least 20% of patients were diarrhea, infusion-related reaction, abdominal pain and fatigue.
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