FDA Approval Insights

Dr. Rini discusses unique elements of the TIVO-3 trial, the significance of the FDA approval of tivozanib in advanced RCC, and potential next steps for research with the TKI in the paradigm.

Dr. Landgren discusses the potential of a quadruplet regimen comprised of carfilzomib, lenalidomide, dexamethasone, and daratumumab in the treatment of patients with newly diagnosed multiple myeloma.

Dr. Sezar and Dr. Stratigos discuss the FDA approvals of cemiplimab-rwlc in advanced non–small cell lung cancer and advanced basal cell carcinoma.

Dr. Abramson discusses the significance of the FDA approval of lisocabtagene maraleucel in refractory large B-cell lymphoma and provided insight into the efficacy and safety profiles of the CAR T-cell therapy as reported in the TRANSCEND NHL 001 trial.

Riad Salem, MD, discusses the unique elements of the TheraSphere, the data that supported the regulatory approval, and the anticipated future for the radioembolization technology in hepatocellular carcinoma.

Dr. Fowler discusses the data that served as the basis for the accelerated approval of umbralisib in marginal zone lymphoma and follicular lymphoma, the implications of the regulatory decision on clinical practice, and potential next steps for the PI3Kδ and CK1ε inhibitor.

Dr. Weiss discusses the significance of the FDA approval of trilaciclib in extensive-stage small cell lung cancer and key efficacy and safety data that have been reported with the CDK4/6 inhibitor.

Dr. Shitara discusses the significance of the FDA approval of trastuzumab deruxtecan in HER2-positive gastric and GEJ adenocarcinoma and key efficacy and safety data that have been reported with the agent.

In our exclusive interview, Paul K. Paik, MD, provides perspective on the FDA approval of tepotinib in MET exon 14-altered metastatic non–small cell lung cancer.

In our exclusive interview, Toni K. Choueiri, MD, provides perspective on the FDA approval of nivolumab and cabozantinib in advanced renal cell carcinoma.

In our exclusive interview, Brian T. Hill, MD, PhD, provides perspective on the FDA approval of selinexor in relapsed/refractory diffuse large B-cell lymphoma.

In our exclusive interview, Saad Z. Usmani, MD, FACP, discusses the FDA approval of daratumumab, carfilzomib, and dexamethasone in relapsed/refractory multiple myeloma.

In our exclusive interview, Vivek Subbiah, MD, discusses the FDA approval of pembrolizumab in tumor mutational burden–high solid tumors, shares the “transformative importance” of the regulatory decision, and speaks to the controversy surrounding the approval.

In our exclusive interview, Dr. Leonard discusses the FDA approval of tazemetostat in patients with relapsed/refractory follicular lymphoma whose tumors are EZH2 positive, as well as those with relapsed/refractory follicular lymphoma who have no other available satisfactory treatment options, and the benefits of providing another agent for this subset of patients.

In our exclusive interview, Antoinette R. Tan, MD, of Atrium Health, discusses the FDA approval of the fixed-dose combination of pertuzumab and trastuzumab in HER2-positive breast cancer and highlights the results of the pivotal FeDeriCa trial.

In our exclusive interview, Jacob Sands, MD, discusses the FDA approval of lurbinectedin in small cell lung cancer and shed light on key findings from the phase 2 basket trial that served as the basis for the approval.

In our exclusive interview, Omid Hamid, MD, contextualizes the FDA approval of atezolizumab in combination with cobimetinib and vemurafenib in BRAF V600 mutation–positive advanced melanoma and discusses important takeaways from the IMspire150 trial.

In our exclusive interview, Shilpa Gupta, MD, of Cleveland Clinic, discusses the FDA approval of avelumab in metastatic urothelial carcinoma and key findings from the JAVELIN Bladder 100 study.

In our exclusive interview, Michael Wang, MD, discusses the FDA approval of brexucabtagene autoleucel in mantle cell lymphoma and ongoing research aimed at optimizing the safety and persistence of the product.

In our exclusive interview, Alexander Drilon, MD provided background on use of targeted therapy in advanced non–small cell lung cancer, discussed the frequency of RET alterations, and expanded on the data from the LIBRETTO-001 trial that led to the accelerated approval of selpercatinib.

Edgardo S. Santos, MD, discusses the data that led to the approval of the combination of ramucirumab and erlotinib in EGFR-mutant metastatic non–small cell lung cancer and shared his thoughts on its utility in the frontline setting.

In our exclusive interview, Neeraj Agarwal, MD, discusses the recent FDA approval of olaparib in homologous recombination repair–mutant metastatic castration-resistant prostate cancer.

In our exclusive interview, Suresh S. Ramalingam, MD, discusses the FDA approval of nivolumab plus ipilimumab for the first-line treatment of patients with metastatic non–small cell lung cancer.

In our exclusive interview, Maria-Victoria Mateos, MD, PhD, discusses the FDA approval of the subcutaneous daratumumab formulation in multiple myeloma.

In our exclusive interview, Maria-Victoria Mateos, MD, PhD, discusses the FDA approval of the subcutaneous daratumumab formulation in multiple myeloma.

In our exclusive interview, Thomas Herzog, MD, discusses the FDA approval of the combination of olaparib (Lynparza) and bevacizumab (Avastin) as frontline maintenance therapy in HRD-positive advanced ovarian cancer.

In our exclusive interview, Aditya Bardia, MD, discusses the FDA approval of sacituzumab govitecan (Trodelvy) in metastatic triple-negative breast cancer.