Chris Ryan

HLX11—a pertuzumab biosimilar—plus trastuzumab/docetaxel met the pCR end point in a phase 3 trial in early or locally advanced HER2-positive breast cancer.

The FDA granted priority review to acalabrutinib for previously untreated mantle cell lymphoma.

MRD negativity was sustained at 1 year following the cessation of maintenance lenalidomide in multiple myeloma.

A sBLA has been submitted to the FDA for subcutaneous daratumumab plus VRd in ASCT-ineligible or -deferred multiple myeloma.

Cadonilimab plus chemotherapy has been approved in China for first-line locally advanced or metastatic gastric/GEJ adenocarcinoma.

Daratumumab plus VRd improved MRD-negativity rates in transplant-ineligible or -deferred, newly diagnosed multiple myeloma.

The FDA’s ODAC voted against the risk:benefit profile of PD-1 inhibitors in first-line advanced gastric/GEJ adenocarcinoma with a PD-L1 of less than 1.

The FDA approved osimertinib for EGFR-mutated, locally advanced, unresectable, non–small cell lung cancer after chemoradiation.

The European Commission has approved toripalimab in indications for nasopharyngeal carcinoma and esophageal squamous cell carcinoma.

LODER plus chemotherapy led to responses and improved overall survival in unresectable, locally advanced pancreatic cancer.

Enfortumab vedotin plus pembrolizumab has been approved in Japan for first-line radically unresectable urothelial carcinoma.

The WHO updated its cervical cancer prevention guidelines to include CINtec PLUS Cytology, a dual-stain cytology test.

The CHMP has recommended the European approval of serplulimab for the first-line treatment of extensive-stage small cell lung cancer.

The CAR T-cell therapy GCC19CART was safe and showed clinical activity in relapsed/refractory metastatic colorectal cancer.

The FDA has approved isatuximab plus bortezomib, lenalidomide, and dexamethasone for newly diagnosed, transplant-ineligible myeloma.

The FDA has granted fast track designation to narmafotinib for the treatment of advanced pancreatic cancer.

The CHMP has issued positive opinions for 2 pembrolizumab-based regimens for select patients with endometrial and cervical cancers.

The FDA has approved amivantamab plus chemotherapy for locally advanced or metastatic NSCLC harboring select EGFR mutations after an EGFR TKI.

Rintatolimod plus durvalumab led to stable disease at 6 months in 2 of 3 patients with late-stage pancreatic cancer treated at the first dose level.

The FDA has granted orphan drug designation to the novel oncolytic virotherapy CF33-hNIS for cholangiocarcinoma.

The FDA has granted regenerative medicine advanced therapy designation to P-BCMA-ALL01 for relapsed/refractory multiple myeloma.

China’s NMPA granted breakthrough therapy designation to belantamab mafodotin plus bortezomib and dexamethasone in relapsed/refractory myeloma.

The FDA has lifted the partial clinical hold previously placed on studies evaluating azenosertib in advanced solid tumors.

TORL-1-23 was safe and active in heavily pretreated, Claudin-6–positive advanced solid tumors, including platinum-resistant ovarian cancer.

Neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, improved overall survival in triple-negative breast cancer.

The FDA has approved subcutaneous atezolizumab for use in all indications as the intravenous formulation.

The FDA has granted orphan drug designation to tebapivat for the treatment of myelodysplastic syndromes.

THIO followed by cemiplimab generated a potential overall survival benefit in third-line advanced non–small cell lung cancer.

Treatment with aumolertinib led to an improvement in progression-free survival in unresectable, stage III, EGFR-mutated non–small cell lung cancer.

HS-20093 produced responses in extensive-stage small cell lung cancer after prior platinum-based chemotherapy with or without prior immunotherapy.