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The FDA has received a supplemental New Drug Application for venetoclax in combination with a hypomethylating agent or low-dose cytarabine as a frontline treatment for patients with acute myeloid leukemia who are ineligible for intensive chemotherapy, Genentech, the manufacturer of the BCL-2 inhibitor, has announced.

An updated analysis of obinutuzumab alone or in combination with chemotherapy for patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia detected no new safety signals. Investigators in the phase IIIb GREEN trial also found overall response rates greater than 80% at 3 months post-treatment in some patients.

Romyelocel-L (human myeloid progenitor cells) has been granted a Regenerative Medicine Advanced Therapy designation by the FDA for the prevention of bacterial and fungal infections in patients with acute myeloid leukemia undergoing induction chemotherapy, according to Cellerant Therapeutics, Inc, the manufacturer of the therapy. RMAT designation holds similar advantages to breakthrough therapy designation.

An accelerated approval has been granted by the FDA for the combination of nivolumab plus ipilimumab for the treatment of both adult and pediatric patients, over the age of 12 years, with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, following progression on treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 

Rami S. Komrokji, MD, recently discussed the treatment considerations and decisions he makes when treating patients with acute myeloid leukemia. Komrokji, professor of oncologic sciences, University of South Florida, and vice chair of the Department of Hematologic Malignancies, Moffitt Cancer Center, explained his treatment decisions based on 2 case scenarios during a <em>Targeted Oncology</em> live case-based peer perspectives presentation.

In an&nbsp;analysis of patients with relapsed/refractory multiple myeloma enrolled on the phase Ib MMY1001 trial, daratumumab (Darzalex) was shown to be safe and effective when added to the backbone of carfilzomib (Kyprolis) and dexamethasone. These findings, which were presented&nbsp;during the 2018 ASCO Annual Meeting, signaled promising efficacy in patients who are refractory to lenalidomide (Revlimid), according to lead study author Ajai Chari, MD.

Consistent benefits and safety were seen with TAS-102&nbsp;(trifluridine/tipiracil; Lonsurf) in a real-world treatment setting for patients with&nbsp;refractory metastatic colorectal cancer, according to preliminary data from the phase IIIb open-label PRECONNECT trial.&nbsp;

Representative Chris Collins recently proposed a bill that could provide the Health Resources and Serves Administration with additional resources to regulate the 340B Drug Discount Program. The 340 Drug Discount Accountability Act was introduced in the House of Representatives on June 27. If passed, the act would require that all participating hospitals document their total 340B drug purchases and pay a user fee of 0.1% to the HRSA.

Jyoti D. Patel, MD, recently shared the treatment considerations and decisions she makes when treating patients with non&ndash;small cell lung cancer. Patel, professor of medicine and director of thoracic oncology at the University of Chicago Medicine in Illinois, discussed her treatment considerations for patients with NSCLC based on case scenarios during a <em>Targeted Oncology </em>live case-based peer perspectives presentation.

According to findings from the&nbsp;IMblaze370 study, atezolizumab alone or in combination with cobimetinib did not demonstrate superior overall survival when compared with regorafenib for the treatment of&nbsp;patients with chemorefractory metastatic colorectal cancer. Findings from the study were presented at the 2018 World Congress on Gastrointestinal Cancer.

Catherine Bollard, MBChB, MD, FRACP, FRCPA, will be bringing the latest cell therapies from the laboratory into clinical application in her new role as associate center director for translational research and innovation at The George Washington University Cancer Center. Bollard is currently a professor of pediatrics and microbiology, immunology, and tropical medicine at the GW School of Medicine and Health Sciences.

According to findings from the&nbsp;phase III KEYNOTE-061 study, second-line treatment with pembrolizumab (Keytruda) did not significantly improve overall survival or progression-free survival compared with&nbsp;paclitaxel&nbsp;in patients with advanced or metastatic gastric or gastroesophageal junction cancer with a PD-L1 combined positive score &ge;1.

Three oncology researchers whose discoveries have advanced the field of targeted therapies in cancer care are jointly being awarded the 2018 Tang Price in Biopharmaceutical Science, which will be presented during a ceremony on September 21 in Taipei, Taiwan.

The FDA approved several indications in the month of June, including venetoclax (Venclexta) in chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL), the combination of binimetinib (Mektovi) plus encorafenib (Braftovi) in melanoma, and bevacizumab (Avastin) in ovarian cancer. The FDA also accelerated approvals for pembrolizumab (Keytruda) in cervical cancer and in primary mediastinal large B-cell lymphoma, while also granting a priority review to glasdegib for acute myeloid leukemia.