The FDA has granted accelerated approval to selpercatinib (Retevmo®, Eli Lilly and Company) for treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) gene fusion solid tumors that have progressed on prior systemic therapy, or who have no adequate alternative treatment options. "Selpercatinib, a highly selective RET kinase inhibitor with central nervous system (CNS) activity, was developed specifically to treat patients with RET-altered cancers," wro...

The FDA has granted regular approval selpercatinib (Retevmo®, Eli Lilly and Company) for treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) gene fusion non-small cell lung cancer (NSCLC). Selpercatinib previously received an accelerated approval from the FDA based on its initial trial results in May 2020. This comes in combination with an FDA approval of the Oncomine Dx Target (ODxT) Test (Thermo Fisher Scientific) as a companion diagnostic for s...

The FDA has approved durvalumab (Imfinzi®, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for treatment of locally advanced or metastatic biliary tract cancer. "Biliary tract cancer, a heterogeneous group of malignancies that includes intrahepatic and extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of Vater cancer, is typically diagnosed at advanced stages, for which curative surgery is not feasible and prognosis is poor," wrote Do-Youn Oh, MD, PhD, Profes...

The FDA has approved ibrutinib (Imbruvica®, Pharmacyclics LLC) for treatment of pediatric patients with chronic graft-versus-host disease (cGVHD) following failure of one or more lines of systemic therapy. "Pediatric cGVHD, a potentially debilitating, life-threatening complication of allogeneic hematopoietic stem cell transplantation, has limited treatment options," wrote Marco Zecca, MD, Director of the Pediatric Oncology/Hematology Unit at the Fondazione IRCCS Policlinico San Matteo in Italy, ...

The FDA has granted accelerated approval to fam-trastuzumab deruxtecan-nxki (T-DXd) (Enhertu®, Daiichi Sankyo Inc.) for treatment of adult patients with unresectable or metastatic non–small cell lung cancer (NSCLC) with human epidermal growth factor receptor 2 (HER2) mutations. This approval is specific to individuals who have undergone previous systemic therapy. Trastuzumab deruxtecan is the first drug to be approved for treatment of HER2-mutant NSCLC. "HER2 mutations are an established molecul...

The FDA has granted regular approval to capmatinib (Tabrecta®, Novartis Pharmaceuticals Corp.) for treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) who have tumors evolving into the mesenchymal-epithelial transition exon 14 skipping (METex14) mutation. Capmatinib was previously granted accelerated approval in May 2020 based on initial data from the GEOMETRY mono-1 trial (NCT02414139); due to updated results, the FDA is now converting it to regular approval. "Activat...

The FDA has approved darolutamide (Nubeqa®, Bayer HealthCare Pharmaceuticals Inc.) in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). "Standard treatment for patients with metastatic, hormone-sensitive prostate cancer includes the addition of either docetaxel or an androgen-receptor pathway inhibitor to androgen-deprivation therapy," wrote Matthew Smith, MD, PhD, Director of the Genitourinary Malignancies Program at the Massachusetts Gener...

The FDA has approved fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)–low breast cancer. This treatment is indicated for patients who have previously undergone chemotherapy in the metastatic setting or who developed disease recurrence during or within six months of completing adjuvant chemotherapy. "Currently available HER2-directed therapies have not improved clinical outcomes in p...

The FDA has granted approval to crizotinib (Xalkori®, Pfizer) for treatment of unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)–positive inflammatory myofibroblastic tumors (IMTs) in adult or pediatric patients one year and older. "ALK is a receptor tyrosine kinase (RTK) that is known to be oncogenically activated by point mutations within the tyrosine kinase domain, copy-number amplification, or chromosomal translocations" wrote Jennifer Foster, MD, MPH, Dire...

The FDA has granted approval to lisocabtagene maraleucel (liso-cel) (Breyanzi®, Bristol Myers Squibb™) for treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after one prior therapy who have become R/R within 12 months of first-line therapy, or who have become R/R after the first line of therapy and are not eligible for hematopoietic stem cell transplant (HSCT). The approval was based on the phase 3 TRANSFORM trial (NCT03575351) and the phase 2 PILOT study (NCT0...

The FDA has given accelerated approval to dabrafenib (Tafinlar®, Novartis) in combination with trametinib (Mekinist®, Novartis) for treatment of adult or pediatric patients with unresectable or metastatic solid tumors with a BRAF V600E mutation and no satisfactory alternative treatment options. This approval is based on three clinical trials: the Rare Oncology Agnostic Research (ROAR) phase 2 basket study, the NCI-MATCH Subprotocol H study, and Study X2101 which was specific to the enrollment of...

The FDA has approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with fluoropyrimidine with platinum-based chemotherapy, and nivolumab in combination with ipilimumab (Yervoy®, Bristol Myers Squibb) for treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). "Esophageal cancer causes more than half a million cancer-related deaths worldwide each year, with squamous cell carcinoma accounting for approximately 85% of cases," wrote Yuichiro Doki, MD, ...

The FDA has given accelerated approval to tisagenlecleucel (Kymriah®, Novartis) for treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL) within six months of receiving two or more lines of systemic therapy or if the patient relapsed after an autologous hematopoietic stem cell transplant. "Follicular lymphoma is a common non-Hodgkin lymphoma that is generally considered indolent, but the disease remains incurable, and the majority of patients eventually relapse," wrote...

The FDA has approved ivosidenib (Tibsovo®, Servier Pharmaceuticals) in combination with azacitidine (Vidaza®, Celgene) for patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) who are at least 75 years old or who have comorbidities preventing them from receiving intensive induction chemotherapy. "Mutant IDH1 catalyzes the production of D-2-hydroxyglutarate, leading to disruption in cellular metabolism and epigenetic regulation and contributing to oncogenesis," wrote Pau Montes...

The FDA has approved azacitidine (Vidaza®, Celgene) for patients with newly diagnosed juvenile myelomonocytic leukemia (JMML), prior to allogeneic hematopoietic stem cell transplantation (HSCT). "JMML is a rare, unique myeloproliferative/myelodysplastic neoplasia of early childhood driven by canonical Ras-pathway mutations in PTPN11, NRAS, KRAS, NF1, or CBL," wrote Charlotte M. Niemeyer, MD, Professor and Medical Director in the Department of Pediatric Hematology and Oncology at Medical Center F...

The FDA has approved fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo, Inc.) for treatment of patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)–positive breast cancer. The approval is specific to individuals who have had prior treatment with an anti–HER2-based regimen in the metastatic, neoadjuvant, or adjuvant setting and have developed disease recurrence within six months of completing therapy. "Although HER2-targeted therapies have improved dise...

The FDA has approved axicabtagene ciloleucel (Yescarta®, Kite Pharma, Inc.) for treatment of adult patients with large B-cell lymphoma (LBCL). Axicabtagene ciloleucel, also known as axi-cel, is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. It is indicated as a second-line treatment for patients who have already undergone first-line chemoimmunotherapy with no response or who have experienced relapse within 12 months of first-line chemoimmunotherapy. It is noted that axic...

The FDA has approved lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617) (Pluvicto™, Advanced Accelerator Applications, Novartis) for the treatment of patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC) who have undergone treatment with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. In addition, the FDA approved gallium-68 gozetotide (68Ga-PSMA-11) (Locametz®, Novartis), a radioactive diagnostic agent ...

The FDA has approved pembrolizumab (Keytruda®, Merck) as a monotherapy for patients with advanced endometrial carcinoma that is microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression subsequent to systemic therapy and are not eligible for curative therapy or radiation. In addition, the FDA also approved the VENTANA MMR RxDx Panel (Ventana Medical Systems, Roche Tissue Diagnostics) to be used as a companion diagnostic device for selecting eligible...