News

Lorlatinib demonstrated an improvement in progression-free survival compared with crizotinib as treatment of patients with treatment-naïve advanced ALK-positive non–small cell lung cancer, meeting the primary end point of the phase 3 CROWN trial.

In an interview with Targeted Oncology, Guillermo Garcia-Manero, MD, discussed the FDA’s recent approval of oral decitabine and cedazuridine as treatment of patients with myelodysplastic syndromes and the data that supported this decision.

Patients with hepatocellular carcinoma, or primary liver cancer, treated with ThermoDox plus radiofrequency ablation in the phase 3 OPTIMA clinical trial will continue to be followed for overall survival.

In an interview with Targeted Oncology, C. Ola Landgren, MD, PhD, discussed the development of CAR T-cell therapy in the treatment landscape of multiple myeloma.

Early rituximab intensification during treatment with R-CHOP demonstrated no difference in outcomes as treatment of patients with diffuse large B-cell lymphoma.

Lenalidomide in combination with rituximab (Rituxan, R2) induction has the ability to achieve high rates of complete molecular response (CMR), similar to rituximab plus chemotherapy, when used as frontline therapy in patients with follicular lymphoma (FL), according to results from the phase 3 RELEVANCE trial (NCT01650701).

Tisagenlecleucel, a chimeric antigen receptor T-cell therapy, showed evidence of clinical benefit for patients with relapsed or refractory follicular lymphoma, in terms of complete response rate, meeting the primary end point of the phase 2 ELARA clinical trial.

The FDA has granted a Fast Track designation to BST-236 for the treatment of patients with acute myeloid leukemia who are 75 years or older or have comorbidities that preclude the use of intensive induction chemotherapy.

Blinatumomab as salvage therapy for patients with relapsed/refractory diffuse large B-cell lymphoma may induce durable complete responses and a survival benefit, according to a pooled analysis of 3 clinical trials.

The FDA has granted an Orphan Drug designation to SM-88 for the potential treatment of patients with pancreatic cancer.

The immune checkpoint inhibitor pembrolizumab appeared well-tolerated with encouraging antitumor activity as treatment of patients with non-muscle invasive bladder cancer who are unresponsive to Bacillus Calmette-Guerin, according to the updated follow-up from the phase 2 KEYNOTE-057 clinical trial.

Updated findings from phase 3 APOLLO show an improvement in progression-free survival with daratumumabe plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone alone.

The FDA has approved tafasitamab-cxix in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specific, including DLBCL arising from low-grade lymphoma, and patients who are not eligible for autologous stem cell transplant.

In response to the COVID-19 pandemic, the European Society of Medical Oncology has published recommendations for the management of patients with lung cancer to maintain high-quality standards of treatment.

Targeted Oncology reviews trending news online for the week of July 31, 2020, including recent news from the FDA, updates in oncology, and new information regarding COVID-19.

Here is a look back at the FDA happenings from the month of July 2020.

Axicabtagene ciloleucel demonstrated a similar overall response rate in both the trial and non-trial settings as treatment of patients with relapsed or refractory large B-cell lymphoma.

The FDA granted approval to atezolizumab in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600E-mutated advanced melanoma.

The FDA has accepted a supplemental Biologics License Application submitted for neoadjuvant pembrolizumab combined with chemotherapy and adjuvant pembrolizumab monotherapy for the treatment of patients with high-risk early-stage triple-negative breast cancer.

The FDA accepted a supplemental Biologics License Application for and granted Priority Review to pembrolizumab in combination with chemotherapy, which is intended for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1.

The FDA has approved the Ventana HER2 Dual ISH DNA Probe Cocktail assay as a companion diagnostic for trastuzumab and for the detection of the HER2 biomarker in patients with breast cancer.

The FDA granted Breakthrough Therapy designation to osimertinib as adjuvant treatment of patients with stage IB-IIIA EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.

The FDA granted a Breakthrough Therapy Designation to the investigational agent pevonedistat as treatment of patients with higher-risk myelodysplastic syndrome.

A Biologics License Application has been submitted to the FDA for the use of idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma

The combination of pembrolizumab plus nab-paclitaxel demonstrated clinically meaningful and sustainable responses, along with prolonged progression-free survival when administered as salvage therapy to patients with metastatic urothelial carcinoma.

There was no difference in the occurrence of late toxicities between patients treated with radiotherapy alone or radiotherapy with short-term androgen deprivation therapy.

Researchers conducted the first known health-related quality of life single-institution study to gather data on patients with Waldenstrom macroglobulinemia, which showed positive and negative health-related quality of life outcomes for patients, following effective treatment.

The FDA granted an Orphan Drug designation to zenocutuzumab for the treatment of patients with pancreatic cancer, announced Merus in a press release.

The FDA has granted a Breakthrough Therapy designation to MK-6482, a novel HIF-2a inhibitor, as treatment of patients with von Hippel-Lindau disease-associated renal cell carcinoma who have non-metastatic tumors that measure less than 3 centimeters in size, unless immediate surgery is needed. The FDA has also granted an Orphan Drug designation to MK-6482 for the treatment of VHL disease alone.

The FDA granted Fast Track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring allosteric HER2 mutation, EGFR mutation, or HER2 exon 20 insertion.