Sara Karlovitch

Here is a look back FDA happenings from July 2021.

The FDA has approved pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy. 

For patients with neuroendocrine tumors, the chances of dying of cancer were higher than dying of other causes, but mortality largely varies by primary tumor site.

Adding berzosertib, a novel ataxia telangiectasia and Rad3-related inhibitor drug, to standard-of-care chemotherapy does not extend progression-free survival for patients with metastatic urothelial cancer.

In an interview with Targeted Oncology™, Eric S. Nadler, MD, discusses IMpower133’s real-world implication and the effects immunotherapy has had on the ES-SCLC space.

Tycel Jovelle Phillips, MD, discusses the design of a phase 1 study looking at venetoclax, lenalidomide, and rituximab in patients with newly diagnosed mantle cell lymphoma.

A new cell therapy containing autologous tumor-infiltrating lymphocytes followed by nivolumab maintenance is both safe and clinically active in patients with metastatic non-small cell lung cancer.

The long-term efficacy of autologous hematopoietic stem cell transplantation in mantle cell lymphoma has been evaluated and confirmed 15 years later.

In an Interview with Targeted Oncology, Debasish Tripathy, MD, discusses the triplet regimen for HER2+ breast cancer with leptomeningeal metastases in greater detail along with its broader clinical applications.

Roxadustat appears to be a well-tolerated, effective treatment for chemotherapy-induced anemia.

In an interview with Targeted Oncology™, lead study author Elisa Agostinetto, MD, of the Istituto Clinico Humanitas in Rozzano, Milan, Italy, discussed the accuracy of PREDICT+ in HER2-positive breast cancer in greater detail and its clinical implications.

The FDA has accepted the biologics license application for tebentafusp and granted it priority review for the treatment of adult patients with HLA-A*02:01-positive metastatic uveal melanoma.

The FDA has approved iIvosidenib Tablets for the treatment of patients with IDH1-mutant cholangiocarcinoma.

In an interview with Targeted Oncology™, Guru Sonpavde, MD, discussed the safety and efficacy of fixed-dose durvalumab for UTC along with an overview of the ongoing CheckMate 274 trial, which evaluates nivolumab compared to placebo in this patient population. 

In medullary thyroid cancer, older patients are more likely to have more aggressive disease and disease specific mortality.

While brain tumor rates are declining, 5-year survival remains low at 36%. Incidence rates of adult brain tumors are decreasing; however, 5-year survival rates remain low.

Enrollment in the phase 2b PARADIGME trial of 177Lu lilotomab satetraxetan (Betalutin) in patients with follicular lymphoma has continued despite the surge of the COVID-19 Delta variant.

The first patient has been dosed in a trial of FHD-609, a selective protein degrader of bromodomain-containing protein 9, for the treatment of synovial sarcoma.

The National Comprehensive Cancer Network has issued support for mandatory COVID-19 vaccinations for health care workers as the FDA issues full approval to the Pfizer-BioNTech COVID-19 vaccine.

The off-the-shelf iPSC-derived NK Cell agents, FT516 AND FT596, which are being developed for the treatment of B-cell malignancies, show promise and early clinical benefit.

In an interview with Targeted Oncology™, Erica Stringer-Reasor, MD, discusses the study in more detail and how this newly approved triplet combination may improve survival for patients living with HER2-positive breast cancer with central nervous system metastases.

In an interview with Targeted Oncology™, Isabelle Ray-Coquard, MD, PhD, discussed the NEOPEMBROV study in greater detail and the benefits of adding pembrolizumab to perioperative treatment for serous carcinoma deemed non-optimally resectable.

The FDA has approved the Ventana MMR RxDx Panel, a companion diagnostic test to determine which patients with DNA mismatch repair deficiency are likely to benefit from the anti-PD-1 monotherapy dostarlimab-gxly.

The Oncoguard Liver liquid biopsy test has demonstrated a high sensitivity and specificy for the detection of hepatocellular carcinoma (HCC), including in patients with early-stage HCC.

The FDA granted an accelerated approval to dostarlimab-gxly (Jemperli), a programmed cell death receptor-1 blocking antibody, for the treatment of adult patients with mismatch repair-deficient recurrent or advanced solid tumors that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

During a recent tweet chat with Alexander M. Lesokhin, MD, a hematologic oncologist with Memorial Sloan Kettering Cancer Center, joined Targeted Oncology to discuss the case of a 72-year-old White man with newly-diagnosed multiple myeloma.

The FDA has granted a fast-track designation to IN10018, a selective ATP-competitive focal adhesion kinase small molecule inhibitor, for the treatment of platinum-resistant ovarian cancer.

The FDA has issued a complete response letter to Sesen Bio, denying the approval of the Biologics License Application for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer.

The first patient has been dosed in a phase 1b/2 trial of AVB-500, a therapeutic recombinant fusion protein, in combination with gemcitabine and nab-paclitaxel for the treatment of advanced pancreatic adenocarcinoma.

The FDA has approved belzutifan for the treatment of Von-Hippel Lindau-associated renal cell carcinoma treated in frontline setting.