Jordyn Sava

The European Commission has granted a conditional marketing authorization to mosunetuzumab for the treatment of adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 prior systemic therapies

Results from JACKPOT8 presented during the 2022 EHA Congress show that golidocitnib has encouraging anti-tumor efficacy and tolerable safety in patients with relapsed or refractory peripheral T-cell lymphoma.

YL-13027 has been dosed for the first time in a patient with advanced solid tumors.

Interim clinical data from a phase 1/2 clinical trial of ST101 in refractory solid tumors leads to the expansion of the phase 2 glioblastoma arm of the study.

The FoundationOne CDx has been granted approval by the FDA to identify patients with ROS1 fusion–positive non–small cell lung cancer or NTRK fusion–positive cancers who might be candidates for entrectinib.

Data from ANTLER presented during the 2022 EHA Congress show initial findings of CB-010 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

A new pan-cancer companion diagnostic indication has been added to the TruSight Oncology Comprehensive test, which will help identify patients who may benefit from targeted therapy with larotrectinib.

Patients with advanced lung cancer harboring neurotrophic tyrosine receptor kinase gene fusions treated with larotrectinib demonstrated positive efficacy and safety.

Rapid and durable responses continue to be demonstrated with larotrectinib in pediatric patients with tropomyosin receptor kinase fusion-positive cancer.

According to Alexander E. Drilon, MD, larotrectinib, regardless of tumor type in adult and pediatric and adult cancers with an NTRK fusion, can demonstrate very robust responses and durable responses.

Phase 3 AGILE results show that ivosidenib plus azacitidine has clinical activity in IDH1-mutant acute myeloid leukemia.

The FDA has withdrawn its approval for the umbralisib, which had previously been approved for marginal zone lymphoma and follicular lymphoma.

In an interview with Targeted Oncology, Manali Kamdar, MD, discussed the current relapsed/refractory B-cell non-Hodgkin lymphoma space, along with data from the phase 1 clinical trial of an anti-CD19 CAR T-cell product for these patients.

Here’s a look back at all of the FDA happenings from May 2022.

Andreas Saltos, MD, discussed treatment options for EGFR and KRAS-mutated NSCLC, and the investigational use of binimetinib to treat these tumors.

The FDA has granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed/refractory follicular lymphoma after receiving 2 or more lines of systemic therapy.

Patients were diagnosed with prostate cancer at the expected average age with a majority of individuals diagnosed with stage 1 or 2 disease, and a significant minority presented with metastases.

The FDA has lifted the partial clinical hold on the phase 1 NEON-2 trial of davoceticept plus pembrolizumab in adult patients with advanced solid tumors or lymphoma.

GEMSTONE-301 showed sugemalimab to demonstrate a statistically significant and clinically meaningful improvement in progression-free survival in patients with unresectable stage 3 non-small cell lung cancer without disease progression after concurrent or sequential chemoradiotherapy.

In an interview with Targeted Oncology following the tweet chat, Omid A. Hamid, MD, discussed the key takeaways from the discussion, including the ways he would treat the patient discussed in the case.

A biologics license application has been submitted to the FDA for N-803 plus Bacillus Calmette-Guérin as treatment for patients with BCG-unresponsive non-muscle invasive bladder cancer in situ with or without Ta or T1 disease.

Melhem Solh, MD, discussed how the post transplantation outcomes for patients with MDS and AML with the TP53 gene mutation have changed to what it is today.

A phase 1b trial of ALRN-6924 in patients with p53-mutated breast cancer who are being treated with doxorubicin plus cyclophosphamide and docetaxel has treated its first patients.

A partial clinical hold has been placed by the FDA on a phase 1 trial examining the use of FHD-286 as treatment for patients with relapsed and/or refractory acute myeloid leukemia and myelodysplastic syndrome.

Priority review to a biologics license application has been granted by the FDA for mirvetuximab soravtansine to treat patients with folate receptor alpha-high platinum-resistant ovarian cancer.

Continuing to monitor trends will be important in regard to the American Thyroid Association developing other updates to its thyroid cancer treatment guidelines and trends.

The FDA allows for an investigational new drug application for the start of the BEXMAB study of bexmarilimab plus standard of care therapy in various hematologic malignancies.

For military veterans, future research should be accompanied by systematic efforts to improve skin cancer prevention, treatment, and outcomes among military service members and veterans, according to Carolyn J. Heckman, PhD.

In an interview with Targeted Oncology, Nicolas Gazeau, further discusses his analysis of anakinra when administered at 2 different dose regimens for patients with refractory CRS/ICANS after CAR T-cell therapy.

A collaboration between Merck and Athenex, Inc. has been announced to evaluate oraxol plus pembrolizumab in certain patients with non-small cell lung cancer.