Kristi Rosa

The European Commission has approved fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received at least 1 anti–HER2-based regimen.

The clinical development of Vicineum for use as a potential therapeutic option in patients with high-risk, Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.

Pralsetinib has been approved in Hong Kong, China, for use in treatment-naïve and pretreated adult patients with RET fusion–positive, metastatic non–small cell lung cancer.

The emergence of novel agents like trastuzumab deruxtecan and tucatinib in the HER2-positive breast cancer treatment paradigm have served to markedly improve outcomes for those with this disease, according to Mark Pegram, MD, who added that the future looks bright.

Pirtobrutinib continued to produce promising responses in heavily pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, irrespective of BTK C481 mutation status, reason for prior BTK inhibitor discontinuation, or other classes of previous therapy received.

The FDA has approved crizotinib for adult and pediatric patients aged 1 year and older with unresectable, recurrent, or refractory inflammatory ALK-positive myofibroblastic tumors.

The FDA has deferred action on the biologics license application seeking the approval of tislelizumab as a second-line treatment in patients with unresectable or metastatic esophageal squamous cell carcinoma, citing the inability to conduct required inspections in China because of travel restrictions associated with COVID-19.

Findings from a phase 1b trial showed that the addition of obinutuzumab to ibrutinib produced a complete response rate that compared favorably with what has historically been observed with ibrutinib monotherapy in patients with relapsed or refractory chronic lymphocytic leukemia.

Camidanlumab tesirine induced an overall response rate of 70.1% in heavily pretreated patients with relapsed or refractory classical Hodgkin lymphoma who previously received brentuximab vedotin and a PD-1 blockade with or without stem cell transplant.

Interim findings from part A of the phase 2/3 RINGSIDE trial indicated that the selective oral gamma-secretase inhibitor, AL102, was found to have favorable tolerability and early antitumor activity in patients with desmoid tumors.

Genmab A/S shared plans to submit a biologics license application to the FDA seeking the approval of subcutaneous epcoritamab for the treatment of patients with relapsed or refractory large B-cell lymphoma in the second half of 2022.

The combination of botensilimab and balstilimab elicited deep objective responses with evidence of durability and encouraging tolerability in heavily pretreated patients with microsatellite stable, metastatic colorectal cancer.

A second-line combination regimen comprised of RGX-202-01, FOLFIRI and bevacizumab demonstrated an encouraging efficacy signal and a favorable toxicity profile in patients with KRAS-mutant colorectal cancer.

The FDA has granted a breakthrough therapy designation to talquetamab for use as a potential therapeutic option in patients with relapsed or refractory multiple myeloma who received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.

The FDA has placed a partial clinical hold on the phase 1/2 NUV-422-02 trial evaluating the selective small molecule CDK2/4/6 inhibitor NUV-422 in patients with solid tumors such as high-grade glioma, hormone receptor–positive advanced breast cancer, and metastatic castration-resistant prostate cancer.

The combination of niraparib and dostarlimab produced a low overall response rate in patients with platinum-resistant ovarian cancer without a known BRCA mutation who had progressed and received prior bevacizumab, one that did not reach the threshold for second-stage accrual to the phase 2 MOONSTONE/GOG-3032 trial.

The combination of amivantamab-vmjw and lazertinib produced encouraging responses with acceptable safety in patients with EGFR-mutated non–small cell lung cancer who progressed on osimertinib and platinum-based chemotherapy.

A new drug application has been submitted to the FDA seeking the approval of elacestrant in the treatment of patients with estrogen receptor–positive, HER2-negative, advanced or metastatic breast cancer.

The FDA has granted an accelerated approval to dabrafenib plus trametinib for the treatment of adult and pediatric patients aged 6 years and older with unresectable or metastatic solid tumors harboring a BRAF V600E mutation who have progressed following previous treatment and who have no satisfactory alternative treatment options.

The FDA has granted an orphan drug designation to the CD20-targeted autologous CAR T-cell therapy, MB-106, for use as a potential therapeutic option in patients with Waldenström macroglobulinemia.

A new drug application seeking the approval of momelotinib for the treatment of patients with myelofibrosis has been submitted to the FDA.

The peptide cancer vaccine onilcamotide failed to show superiority over placebo in terms of preventing progression in patients with prostate cancer and biochemical recurrence following curative-intent therapy, missing the primary end point of the phase 2b BRaVac trial.

The FDA has granted a fast track designation to PDS0101 for use in combination with pembrolizumab in patients with recurrent or metastatic HPV16-positive head and neck cancer.

The PD-L1 antibody cosibelimab was found to elicit an encouraging objective response rate in patients with locally advanced cutaneous squamous cell carcinoma who were not eligible to undergo curative surgery or radiation.

The addition of venetoclax to ibrutinib resulted in a high rate of minimal residual disease negativity in the blood and marrow of patients with previously untreated chronic lymphocytic leukemia.

Teclistamab was found to have improved effectiveness in terms of progression-free survival, time to next treatment, and overall survival vs real-world physician’s choice of therapy in patients with triple-class exposed relapsed/refractory multiple myeloma.

The combination of galinpepimut-S and nivolumab was found to extend survival in patients with malignant pleural mesothelioma who were either refractory to, or who had relapsed after, at least 1 line of standard therapy.

The European Commission has approved atezolizumab for use as an adjuvant treatment following complete resection and platinum-based chemotherapy in adult patients with non–small cell lung cancer and a high risk of recurrence whose tumors do not have EGFR mutations or ALK alterations but have a PD-L1 expression of 50% or higher.

The FDA has accepted for review a new supplemental biologics license application seeking approval of pembrolizumab in the adjuvant treatment of patients with stage IB to IIIA non–small cell lung cancer after complete surgical resection.

Bezuclastinib showcased early signs of clinical activity in that it resulted in a meaningful reduction in serum tryptase levels, as well as reductions in mast cell burden and KIT D816V variant allele frequency, in adult patients with advanced systemic mastocytosis.