Jordyn Sava

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The FDA has withdrawn its approval for the umbralisib, which had previously been approved for marginal zone lymphoma and follicular lymphoma.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

Having an antibiotic de-escalation guideline did not affect the rate of bacterial infection after antibiotic de-escalation, all cause-mortality, or hospital length of stay in patients with acute myeloid leukemia and febrile neutropenia who were clinically stable and afebrile.

Data supporting prostate-specific antigen screening shows harm-benefit tradeoff to be more favorable with complementary approaches to quantifying overdiagnosis.

Long-term follow-up results from the JAVELIN Bladder 100 study further support the standard-of-care role of avelumab as frontline maintenance in patients with urothelial carcinoma.

Investigators of the phase 1/2 IMAGINE study, evaluating MT-101 in patients with refractory or relapsed peripheral T-cell lymphoma, have dosed its first patient.

The use of single-agent odronextamab demonstrated a manageable safety profile and promising preliminary activity in heavily pretreated patients with B-cell non-Hodgkin lymphoma.

The SKYSCRAPER-01 study missed its co-primary end point of progression-free survival in patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer.

Endocrine therapy plus bevacizumab with the possibility of weekly paclitaxel reinduction signals efficacy and demonstrates a good safety profile in patients with ER-positive, HER2-negative advanced or metastatic breast cancer who have responded to induction therapy.