FDA Approvals, News & Updates
In May 2021, the FDA approved Lumakras (sotorasib), an oral KRAS inhibitor, for the treatment of adults with locally advanced or metastatic non–small-cell lung cancer associated with KRAS G12C mutation. Lumakras is the first drug approved for any cancer associated with any KRAS mutation. Read More ›
In April 2021, the FDA approved Zynlonta (loncastuximab tesirine), the first CD19-directed antibody–drug conjugate, for the treatment of patients with relapsed or refractory large B-cell lymphoma. Read More ›
In March 2021, the FDA approved a new indication for Sarclisa (isatuximab-irfc), in combination with Kyprolis and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma. Read More ›
In March 2021, the FDA approved Lorbrena (lorlatinib), a third-generation ALK inhibitor, for first-line treatment of patients with non–small-cell lung cancer and ALK mutation. Lorbrena was previously approved for the second- or third-line treatment for this patient population. Read More ›
In February 2021, the FDA approved Cosela (trilaciclib) as the first CDK4/6 inhibitor to reduce the risk of chemotherapy-induced myelosuppression in adults with extensive-stage small-cell lung cancer. Cosela can prevent damage to bone marrow cells by blocking the CDK4/6 enzyme. Read More ›
There are more treatment options available for breast cancer than ever before – and more are coming. Here’s an overview of the most recently approved medicines. Read More ›
The immunotherapy Libtayo received FDA approval as first-line treatment for patients with advanced or metastatic non–small-cell lung cancer and high PD-L1 expression. Read More ›
The immunotherapy Libtayo is a new treatment option for advanced or metastatic basal-cell carcinoma, a type of skin cancer. Libtayo was initially approved for a different type of skin cancer. Read More ›
Pepaxto is a novel therapy that has shown good results in multiple myeloma that does not respond to other therapies, according to myeloma expert Paul G. Richardson, MD, of Dana-Farber Cancer Institute. Read More ›
Abecma is the first gene therapy approved by the FDA for patients with multiple myeloma. It uses the patient’s own genetically modified T-cells to fight the cancer. Read More ›