Jason M. Broderick

The FDA has issued a complete response letter to Sandoz (Novartis) regarding a biologics license application for the rituximab biosimilar GP2013.

Selinexor induced an overall response rate of 25.4% in patients with penta-refractory multiple myeloma, according to top-line results from part 2 of the phase IIb STORM trial.

The FDA has approved tisagenlecleucel (Kymriah) for use in adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.

The FDA has approved the combination of dabrafenib and trametinib for the adjuvant treatment of patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.

The FDA has granted a priority review to a biologics license application for the PD-1 inhibitor cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not eligible for surgery.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended adding final overall survival data from the phase III ASPIRE trial to the label for carfilzomib for the treatment of patients with relapsed/refractory multiple myeloma.

The FDA has granted a priority review to a supplemental biologics license application for frontline pembrolizumab for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of osimertinib as a first-line treatment for patients with non–small cell lung cancer (NSCLC) whose tumors harbor activating EGFR mutations.

Dual immune checkpoint blockade with durvalumab (Imfinzi) and tremelimumab did not induce a statistically significant improvement in overall survival in heavily pretreated patients with locally-advanced or metastatic NSCLC.

Niraparib (Zejula) met the primary endpoint of overall response as a fourth-line or later treatment in patients with ovarian cancer, regardless of BRCA status, according to top-line results from the QUADRA study.

The FDA has halted enrollment on clinical trials of tazemetostat in patients with various solid tumors and hematologic malignancies.

Citing the need for additional technical information, the FDA has issued a complete response letter to Pfizer regarding a biologics license application for the trastuzumab (Herceptin) biosimilar PF-05280014.

Combining ramucirumab with docetaxel in patients with locally advanced or unresectable metastatic urothelial carcinoma who progressed on platinum-based chemotherapy led to a positive trend, but not a statistically significant improvement, in overall survival.

An interim analysis revealed that the immunotherapy rocapuldencel-T is unlikely to meet any of the primary endpoints of the phase III ADAPT trial in patients with metastatic renal cell carcinoma.

The FDA has approved osimertinib as a first-line treatment for patients with non–small cell lung cancer whose tumors harbor EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations).

The FDA has granted a priority review to a supplemental biologics license application for nivolumab (Opdivo) for the treatment of patients with small cell lung cancer with disease progression following 2 or more lines of therapy.

Adding the IDO1 inhibitor epacadostat to the PD-L1 inhibitor durvalumab (Imfinzi) failed to induce any clinical responses in patients with pancreatic cancer.

Combining pembrolizumab (Keytruda) with standard chemotherapy in the frontline setting reduced the risk of death by over 50% in patients with nonsquamous non–small cell lung cancer without EGFR or ALK mutations.

The FDA has approved the combination of nivolumab and ipilimumab as a frontline treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma.

Adjuvant pembrolizumab (Keytruda) reduced the risk of recurrence or death by 43% in patients with resected, high-risk stage III melanoma, according to phase III results from the EORTC 1325-MG/KEYNOTE-054 trial.

Adjuvant axitinib did not extend disease-free survival versus placebo for patients at high risk of recurrent renal cell carcinoma after nephrectomy, according to findings from the phase III ATLAS trial.

Single-agent treatment with the PD-1 inhibitor pembrolizumab improved overall survival versus chemotherapy as a frontline treatment for patients with locally advanced or metastatic non–small cell lung cancer and a PD-L1 expression level ≥1%.

The FDA has granted a priority review to a new drug application for duvelisib for a full approval for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma.

The FDA has approved rucaparib for use as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

The combination of the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat failed to improve progression-free survival versus single-agent pembrolizumab in patients with unresectable or metastatic melanoma, according to findings from the phase III ECHO-301/KEYNOTE-252 trial.

The FDA has granted a priority review designation to dacomitinib for the frontline treatment of patients with EGFR-positive locally advanced or metastatic non–small cell lung cancer.

The European Commission has approved denosumab for the prevention of skeletal-related events in adult patients with multiple myeloma.

Findings from a small, retrospective study showed that external beam radiation therapy induced an overall response rate of 86% in patients with relapsed/refractory follicular lymphoma.

The FDA has approved blinatumomab for the treatment of patients with minimal residual disease–positive B-cell precursor acute lymphoblastic leukemia.

The FDA has granted a priority review to a supplemental biologics license application for nivolumab plus ipilimumab for the treatment of adult patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.