Robotic Mastectomy Gains FDA Clearance as Researchers Target Drug-Resistant Cancers
FDA has cleared a robotic nipple-sparing mastectomy platform after clinical trials showed excellent results with preserved breast sensation. Researchers are advancing immunotherapy combinations for breast cancer and novel strategies to overcome drug resistance in EGFR-mutated lung cancer, including protein degraders and dual-binding inhibitors.
A robotic nipple-sparing mastectomy procedure has gained FDA clearance as researchers advance novel approaches to overcome drug resistance in breast and lung cancers. The single port robotic platform obtained clearance from the FDA in December 2025, marking a significant milestone for breast cancer surgery innovation.
The robotic surgery was originally controversial but is now largely accepted with FDA approval. A study published in JAMA Surgery in early 2024 reported excellent results among the first 20 patients who underwent the procedure. Since the first surgery in 2020, more than 100 have been performed as part of the clinical trial. Half of the patients had early-stage cancer or were at elevated risk for the disease and reported still having sensation, which is key to maintaining their quality of life after treatment.
Almost all patients in the initial study retained sensitivity in their breasts, addressing a major limitation of traditional approaches. "While modern mastectomy and breast reconstruction have made great strides, most approaches still result in loss of full sensation in the nipple and breast due to nerve damage from large incisions and excessive retraction," explained the surgical oncologist who performed the first robotic nipple-sparing mastectomy in the U.S.
In parallel immunotherapy research, investigators are using preoperative immunotherapy medication pembrolizumab to stimulate the immune system in combination with chemotherapy and HER2-targeting therapy to treat patients with early-stage HER2-positive breast cancer. The results have been significant—about 50% of patients respond to standard preoperative treatment, but when immunotherapy was added to the regimen before surgery, the percentage of patients who responded positively increased by 20%.
Researchers are also investigating a strategy that freezes tumors with cryoablation while simultaneously activating the immune system. By exposing the immune system to tumor cells in this way, they hope to train the body to recognize and fight triple-negative breast cancer.
Meanwhile, in lung cancer research, scientists are developing next-generation therapies to combat drug resistance in EGFR-mutated non-small cell lung cancer (NSCLC). EGFR-mutated NSCLC accounts for about 10-15% of NSCLC in the United States and up to 50% of cases in Asian populations. Osimertinib is one of the leading treatments for EGFR-mutated NSCLC worldwide, but patients typically respond very well initially before developing resistance after one to three years.
The research team has developed a three-fold strategy to approach this problem. First, they created a new EGFR degrader, a class of drug that triggers EGFR's destruction inside the cancer cell. Second, they developed allosteric inhibitors that bind to an alternative binding pocket and inhibit the enzyme in a different manner than traditional drugs. Third, they designed a "molecular bidentate" compound that can form two bonds to EGFR, creating an irreversible covalent bond that makes it much harder for the enzyme to escape the grip of the drug.
This dual-gripping design is currently being evaluated and refined to create a version that can be brought to patients. Across all three approaches, the goal remains the same: to stay one step ahead of drug resistance and give patients with EGFR-mutated lung cancer more effective treatment options.