Nichole Tucker

A new drug application has been resubmitted to the FDA for Pedmark, a sodium thiosulfate formulation, for the prevention of ototoxicity induced by cisplatin-based chemotherapy in patients under the age of 18 years old with localized, non-metastatic solid tumors.

The FDA has accepted and granted priority review to the new drug application for plinabulin in combination with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia in patients with cancer.

Here is a look back at the FDA happenings from the month of May 2021.

The FDA has granted accelerated approval to the oral FGFR1-3 selective inhibitor, infigratinib for the treatment of patients with cholangiocarcinoma who harbor an FGFR2 gene fusion or rearrangement.

The FDA has granted accelerated approval to sotorasib for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

In an interview with Targeted Oncology following the medical conference presentation, Ritu Salani, MD, expanded on the role biomarkers play in the treatment of cervical cancer, how this testing looks in the everyday clinics, and how it can potentially change pending competition of ongoing clinical trials.

The FDA has granted approval to piflufolastat F 18 injection, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent, to identify patients who may have metastasis or recurrence of prostate cancer.

Idecabtagene vicleucel is now an available treatment option for some patients with relapsed or refractory multiple myeloma who are being treated at Seattle Cancer Care Alliance.

The case of a 75-year-old man with stage T2N0M0 prostate cancer was the topic of discussion between 8 oncologists, a physicians assistant, and a nurse practitioner during a recent Targeted Oncology Case-Based Roundtable event moderated by Daniel Landau, MD.

Deeper remissions in patients with newly diagnosed, high-risk/secondary acute myeloid leukemia may be achieved with CPX-351 treatment and lead to improvement in overall survival, according to post hoc analyses of a phase 3 study.

A biologic license application has been submitted to the FDA for the PD-1 monoclonal antibody drug penpulimab for the third-line treatment of metastatic nasopharyngeal carcinoma.

On the second day of a 2-day meeting of the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drug Advisory Committee, members and guests brought into question the role of real-world data in regulatory decision-making for pediatric oncology drugs.

The FDA has granted approval to amivantamab-vmjw for the frontline treatment of adult patients with non-small cell lung cancer whose tumors have EGFR exon 20 insertion mutations.

Tislelizumab, an anti-PD-1 antibody combined with gemcitabine and cisplatin demonstrated improvement in progression-free survival (PFS) compared with chemotherapy as first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer, meeting the primary end point of the phase 3 RATIONALE 309 trial, according to a press release by BeiGene, Ltd.

The FDA granted approval to adjuvant nivolumab as treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy.

A standing question for oncologists is what to do for patients with tumors smaller than 2 cm. The question led to a debate on whether to administer neoadjuvant chemotherapy to patients with T1c hormone receptor–negative, HER2-positive breast cancer during the 38th Annual Miami Breast Cancer Conference.

The FDA has granted a fast track designation to the autologous chimeric antigen receptor T-cell agent, AIC100, for the treatment of patients with anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer.

In an interview with Targeted Oncology, Naseema Gangat, MD, MBBS, discussed her recommendations for managing pregnant patients with myeloproliferative neoplasms.

The FDA has accepted a biologics license application or sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with nonsquamous non-small cell lung cancer.

A phase 3 study showed that patients with platinum-sensitive recurrent ovarian cancer experienced improved progression-free survival on chemotherapy plus bevacizumab continued beyond disease progression.

Overall survival was prolonged in patients with radioactive iodine-refractory differentiated thyroid cancer and lung metastases larger than 1 cm who were treated with lenvatinib in the SELECT study.

In an interview with Targeted Oncology following a webinar, Benjamin O. Anderson, MD, FACS, discussed lessons from COVID-19 in further detail.

The FDA has granted orphan drug designation to the first-in-class ruthenium-based small molecule, BOLD-100, for the treatment of patients with gastric cancer.

Treatment with neratinib demonstrated a modest overall survival benefit in patients with HER2-positive breast cancer compared with placebo, according to the long-term OS and central nervous system results from the phase 3 ExteNET trial.

In an interview with Targeted Oncology, Vivek Subbiah, MD, reviewed the data supporting selpercatinib as treatment of RET fusion-positive thyroid cancers, as well as the exploration of this agent in other RET-altered cancers.

The FDA has granted priority review to 2 supplemental new drug applications for the combination use of pembrolizumab and lenvatinib.

Patients with mantle cell lymphoma treated with second-line ibrutinib or the R-BAC regimen experienced improvement in progression-free survival 2 compared with treatment on rituximab and bendamustine and other regimens, according to findings from the international, retrospective MANTLE-FIRST study.

The FDA has granted accelerated approval to pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction cancer.

The FDA accepted a supplemental new drug application for ivosidenib tablets and granted it priority review for the treatment of patients with previously treated IDH1-mutated cholangiocarcinoma.

Findings from the PROfound and National Comprehensive Cancer Network guidelines for molecular testing were reviewed for a discussion on treatment for 60-year-old man with metastatic castration-resistant prostate cancer.