Gina Columbus

The FDA has granted a priority review designation to a supplemental new drug application for rucaparib for the treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castration-resistant prostate cancer.

The FDA has granted a priority review designation to a supplemental biologics license application for the combination of nivolumab and ipilimumab for the first-line treatment of patients with metastatic or recurrent non–small cell lung cancer that does not have EGFR or ALK genomic tumor aberrations.

The first-line combination of sintilimab injection plus pemetrexed and platinum-based therapy showed a statistically significant improvement in progression-free survival compared with chemotherapy and placebo in patients with advanced or recurrent nonsquamous non–small cell lung cancer who did not harbor EGFR or ALK abnormalities, according to an interim analysis of the phase III ORIENT-11 trial.

The FDA has granted a priority review designation to a supplemental new drug application for the combination of olaparib and bevacizumab for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab.

The FDA has approved avapritinib for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.

The FDA has placed a partial clinical hold on the TELLOMAK trial, which is evaluating the efficacy and safety of lacutamab in patients with advanced T-cell lymphoma.

Loncastuximab tesirine demonstrated an overall response rate of 45.5% in patients with relapsed/refractory diffuse large B-cell lymphoma, including those who are difficult to treat.

The RET inhibitor pralsetinib demonstrated encouraging and durable responses in patients with RET fusion–positive non–small cell lung cancer who were both treatment-naïve and received prior treatment with platinum-based chemotherapy.

The FDA has approved pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

The combination of pembrolizumab and chemotherapy improved progression-free survival compared with chemotherapy alone as a first-line treatment for patients with extensive-stage small cell lung cancer.

The United Kingdom’s National Institute for Health and Care Excellence did not recommend granting marketing authorization to atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the treatment of patients with treatment-naïve extensive-stage small cell lung cancer.

The combination of itacitinib and corticosteroids did not induce a statistically significant improvement in overall response rate at day 28 compared with placebo plus corticosteroids in patients with treatment-naïve acute graft-versus-host disease, missing the primary endpoint of the phase III GRAVITAS-301 trial.

Frontline maintenance therapy with avelumab plus best supportive care demonstrated a statistically significant improvement in overall survival compared with best supportive care alone in patients with previously untreated locally advanced or metastatic urothelial carcinoma, regardless of PD-L1 expression.

Poziotinib did not meet its primary endpoint of overall response rate in patients with previously treated EGFR-mutant non–small cell lung cancer who have exon 20 insertion mutations.

The FDA has accepted a biologics license application to review eflapegrastim for the management of chemotherapy-induced neutropenia.

Japan’s Pharmaceuticals and Medical Devices Agency has approved the combination of pembrolizumab and axitinib for the first-line treatment of patients with radically unresectable or metastatic renal cell carcinoma.

The FDA has granted an accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.

Japan's Pharmaceuticals and Medical Devices Agency has granted approval to frontline pembrolizumab as monotherapy and in combination with chemotherapy for the treatment of patients with recurrent or distant metastatic head and neck cancer.

A biologics license application has been submitted to the FDA for the rituximab biosimilar ABP 798.

The European Commission has approved ado-trastuzumab emtansine for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease (breast and/or lymph nodes) following neoadjuvant taxane-based chemotherapy and HER2-targeted therapy.

Everett E. Vokes, MD, FASCO, who is a Giants of Cancer Care® recipient for Head and Neck Cancer, has been named the next president of ASCO for the 2021 to 2022 term.

The FDA has granted a priority review designation to a new drug application for UGN-101 for the treatment of patients with low-grade, upper tract urothelial cancer.

A new drug application has been submitted to the FDA for tazemetostat as a treatment for patients with relapsed/refractory follicular lymphoma, with or without EZH2 activating mutations, who have received ≥2 prior lines of systemic therapy.

The FDA has granted a priority review designation to a supplemental new drug application for the combination of encorafenib and cetuximab as a treatment for patients with advanced BRAF V600E­–mutant metastatic colorectal cancer following up to 2 prior lines of therapy.

The FDA’s Oncologic Drugs Advisory Committee voted in favor of approving tazemetostat tablets as a treatment for patients with metastatic or locally advanced epithelioid sarcoma that is ineligible for curative surgery.

The FDA has granted a breakthrough therapy designation to ivosidenib for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes who harbor IDH1 mutations.

The FDA’s Oncologic Drugs Advisory Committee voted 7 to 5 in favor of olaparib tablets for an indication as a maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutant metastatic pancreatic adenocarcinoma whose disease has not progressed on frontline platinum-based chemotherapy.

The FDA has approved a supplemental new drug application for enzalutamide (Xtandi) for the treatment of patients with metastatic castration-sensitive prostate cancer.

Zanubrutinib did not show a statistically significant improvement in complete response and very good partial response rates compared with ibrutinib in patients with Waldenström macroglobulinemia, missing the primary endpoint of the phase III ASPEN trial.

A new drug application has been submitted to the FDA for ripretinib for use as a treatment for patients with advanced gastrointestinal stromal tumors who have previously received treatment with imatinib, sunitinib, and regorafenib.