The Food and Drug Administration has had a busy winter so far, approving several new agents to treat a variety of cancers. Here are seven recent approvals that patients with cancer may have missed.
The Food and Drug Administration (FDA) has approved several drugs in the cancer space over the last several weeks.
The agency is expected to continue to approve more oncology therapies over the next few months, but in case you missed it, CURE® compiled a list of the seven most recent FDA approvals.
Riabni, a Rituxan Biosimilar, For Patients with Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Two Blood Vessel Disorders
Among 256 patients, Riabni (rituximab-arrx) had a similar clinical equivalence to Rituxan (rituximab) by week 28 when assessing for overall response to therapy. READ MORE.
Xpovio for Use with Velcade and Dexamethasone in Multiple Myeloma
Progression-free survival (PFS) in patients assigned Xpovio with Velcade and low-dose dexamethasone was 13.9 months compared with 9.5 months in patients assigned Velcade with dexamethasone, which contributed to a 47% increase in median PFS. READ MORE.
Orgovyx to Treat Advanced Prostate Cancer in Adults
Common side effects with Orgovyx (relugolix) include increased glucose, hot flash, musculoskeletal pain, increased triglycerides, fatigue, decreased hemoglobulin, diarrhea, constipation and increases in certain liver enzymes, according to the release. READ MORE.
Tagrisso as Adjuvant Therapy for Non-Small Cell Lung Cancer After Tumor Resection
Median disease-free survival, the major efficacy outcome of the trial, was not reached in the Tagrisso (Osimertinib) group compared with 19.6 months in the placebo group. READ MORE.
Iclusig (Ponatinib) for Adult Patients with Resistant/Intolerant Chronic-Phase CML
This is an updated label for the agent, which now includes an optimized response-based dosing regimen of Iclusig: a daily starting dose of 45 mg and, upon achieving less than or equal to a 1% BCR-ABL1IS (a gene sequence found in an abnormal chromosome 22 of some people with certain forms of leukemia), dose reduction to 15 mg. READ MORE.
Xalkori for Children, Young Adults with Relapsed or Refractory Anaplastic Large Cell Lymphoma
In the ADVL0912 trial, 26 patients between the ages of 1 and 21 with relapsed or refractory, systemic ALK-positive ALCL were enrolled, all of whom had at least one prior systemic therapy. In these participants, treatment with Xalkori (crizotinib) induced an objective response rate (the proportion of patients who had a complete or partial response to treatment) of 88%. READ MORE.
Enhertu for Gastroesophageal, Gastric Cancer Subset
Patients in the Enhertu (Fam-trastuzumab deruxtecan-nxki) arm achieved a median overall survival of 12.5 months, compared to 8.4 months in those who received physician’s choice of therapy. The objective response rate was 40.5% in those who received the trial drug, versus 11.3% in patients who were administered either irinotecan or paclitaxel. READ MORE.
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