Throughout 2024, the Food and Drug Administration (FDA) approved many cancer treatments, benefitting patients with different types of cancer.
CURE compiled a list of the top FDA approval stories throughout the year, with diseases including gynecologic cancer, breast cancer, multiple myeloma and pancreatic cancer, among others.
Elahere Gets Full Approval for Pretreated Gynecologic Cancer
In March 2024, the FDA granted Elahere (mirvetuximab soravtansine–gynx) full approval to treat gynecologic cancers, particularly patients with previously treated folate receptor α (FRα)–positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Elahere is a type of immunotherapy drug that works by helping the body's immune system to fight cancer cells.
The FDA approved Elahere based on the results of the MIRASOL trial, which showed that Elahere was more effective than chemotherapy at treating gynecologic cancers. Patients who received Elahere had a longer time before their cancer progressed and a longer overall survival time than patients who received chemotherapy.
Glossary:
Overall survival: the time from diagnosis or the start of treatment when a patient with cancer is still alive.
Biosimilar: a biological medicine that is highly similar to an already approved biological medicine. Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy as the already approved product.
Objective response rates: patients whose disease responded partially or completely to treatment.
Hypokalemia: low levels of potassium.
Neutropenia: low levels of white blood cells.
Progression-free survival: The time a patient lives without their disease spreading or worsening.
Peripheral neuropathy: weakness, numbness and pain in the hands and feet.
Edema: fluid that causes swelling in the extremities.
The most common side effects of Elahare included fatigue, blurred vision, digestive issues, muscle or joint pain and changes in blood tests that may indicate liver dysfunction and low blood cell counts.
On-Body Administration of Neulasta Biosimilar
The FDA approved another way to administer Udenyca (pegfilgrastim-cbqv), a biosimilar medication to Neulasta (pegfigrastim), in January 2024. Udenyca is used to boost white blood cell counts after chemotherapy, which can be depleted by treatment. Traditionally, Udenyca was injected into a vein. However, this approved method allows for the medication to be injected under the skin.
Udenyca Onbody is worn directly on the patient’s body and injects Udenyca into the patient. After the drug is administered, the needle automatically retracts, which, according to the release, can reduce the risk of injury from the needle. The device also has an indicator and status light, as well as an auditory signal that helps patients confirm that Udenyca has been administered.
Onivyde as First-Line Treatment of Metastatic Pancreatic Cancer
In February 2024, the FDA approved Onivyde (irinotecan liposome) with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of patients with metastatic pancreatic adenocarcinoma.
The approval of Onivyde was based on the results of a clinical trial that demonstrated an improvement in overall survival and the time before the cancer progressed compared to a standard treatment. In addition, the objective response rates were 41.8% and 36.2% when treated with NALIRIFOX regimen of Onivyde, oxaliplatin, leucovorin and fluorouracil or the Gem+NabP regimen of nab-paclitaxel and gemcitabine, respectively.
The most common grade 3 and 4 (severe to life-threatening) treatment-emergent side effects in the NALIRIFOX group compared with those in the nab-paclitaxel and gemcitabine group included diarrhea (20.3% versus 4.5%), nausea (11.9% versus 2.6%), hypokalemia (15.1% versus 4%), anemia (10.5% versus 17.4%) and neutropenia (14.1% versus 24.5%).
Enhertu for Some With HER2-Positive Solid Tumors
Enhertu (fam-trastuzumab deruxtecan-nxki) received an accelerated approval from the FDA in April 2024, for certain patients with HER2-positive solid tumors. Patients eligible for this accelerated approval include individuals who have unresectable (not surgically unremovable) or metastatic HER2-positive solid tumors who have previously received systemic treatment. Eligible patients also do not have satisfactory alternatives for treatment, according to the announcement from the FDA.
The approval was based on data from three clinical trials: DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02. These trials evaluated Enhertu's effectiveness in 192 patients with previously treated, unresectable or metastatic HER2-positive tumors.
Key measures of success included the objective response rate, which indicates how many patients experienced tumor shrinkage or disappearance, and the duration of response, which measures how long the treatment effectively controlled the tumor.
Common side effects observed in patients treated with Enhertu included decreased white blood cell counts, nausea, decreased hemoglobin (low red blood cell count), fatigue, decreased lymphocyte counts (a type of white blood cell), and decreased platelet counts.
Darzalex Faspro Regimen for Some With Multiple Myeloma
In July 2024, the FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone (a regimen called Darzalex Faspro-VRd) for induction and consolidation in patients with multiple myeloma. Of note, patients eligible for this treatment regimen are newly diagnosed with multiple myeloma and are eligible for an autologous stem cell transplant
This approval was based on findings from the PERSEUS trial. This trial compared Darzalex Faspro to the standard treatment of Velcade, Revlimid and dexamethasone. The results showed that Darzalex Faspro improved progression-free survival compared to the standard treatment.
In terms of side effects, the most common ones that occurred in approximately 20% or more included peripheral neuropathy, fatigue, edema, fever, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia and rash.
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