Sara Karlovitch

GC012F, a duel target BCMA/CD19 CAR T-cell therapy was granted an orphan drug designation after durable responses were seen in a phase 1 study of the agent.

The phase 2b AIPAC study, Eftilagimod alpha was found to improve overall survival in metastatic breast cancer along with a tolerable safety profile.

Fourteen practices from the US Oncology Network Participate in the Oncology Care Model.

The FDA has approved adjuvant pembrolizumab for the treatment of renal cell carcinoma with an intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

Data presented at an ASCO Plenary session found that digitally monitoring patient-reported outcomes helped to improve outcomes and quality of life.

The National Comprehensive Cancer Network has updated its guidelines on ALL in adolescents and young adults.

The phase 3 JUPITER06 study of toripalimab found that compared with a placebo, it significantly improved progression-free and overall survival.

Subasumstat was found to have a manageable safety profile along with preliminary anti-tumor activity in patients with advanced or metastatic solid tumors or relapsed/refractory lymphoma.

Epcoritamab should be evaluated further after positive phase 1/2 results showing the agent was safe with preliminary antitumor activity.

In an interview with Targeted Oncology™, Corey S. Cutler, MD, MPH, FRCPC, discussed the impact belumosudil has made on the chronic GVHD space.

A California-based study of devimistat plus hydroxychloroquine for soft tissue sarcoma has enrolled its first patient.

In the Chinese population of the global INVICTUS trial, ripretinib was found to have a manageable safety profile and produced a good response rate.

Yuliya Mikheeva, MD, PhD, of Saint Petersburg State University, discusses the prognosis of patients with anaplastic thyroid cancer.

Over abiraterone/prednisone alone, apalutamide plus abiraterone-prednisone proves survival benefit in patients with metastatic castration resistant prostate cancer.

Bemcentinib is currently being studied in combination with pembrolizumab and has demonstrated a good safety profile.

Ocular adnexal region involvement remains rare, presenting in only between 1% to 5% of mantle cell lymphoma cases.

In an interview with Targeted Oncology, Rachna Shroff, MD, discusses the impact of ivosidenib’s approval on the cholangiocarcinoma space in greater detail.

DF1001 is currently being studied as both a monotherapy and a combination in a phase 1/2 study that is now recruiting across the United States.

The combination of lenvatinib and pembrolizumab is the current standard of care for ccRCC, however, most patients still experience disease progression. The addition of a third agent may lead to improvement in outcomes.

The additional of nivolumab to chemotherapy improved event-free surivial in patients with resectable non-small cell lung cancer, meeting the primary end point of the CheckMate 816 trial.

The agent, EZM0414, will be explored in DLBCL, multiple myeloma, and non-multiple myeloma after the completion of a phase 1 dose-finding study.

Compared with sunitinib, the combination of nivolumab an ipilimumab produced better long-term responses, with overall survival approaching 5 years.

James Brugarolas, MD, PhD, discusses updated survival data in patients with metastatic renal cell carcinoma.

While immunotherapy has high and durable response rates, most patients die of the disease.

Limited data exists on the effects of palliative care in patients with kidney cancer, and more research is needed.

The phase 3 COMPOSE trial is the second trial to look at 177Lu-edotreotide in somatostatin receptor-positive disease.

The novel PARP inhibitor RP12146 has been administered to the first patient in a phase 1/1b clinical trial of patients with advanced solid tumors.

Filip Janku, MD, PhD, discussed the efficacy of the PI3K inhibitor copanlisib in solid tumors in an interview with Targeted Oncology.

The PDUFA date for Cilta-Cel has been moved in order to evaluate new data and is now set for early 2022.

Here is a look back FDA happenings from October 2021.