FDA Updates

Selpercatinib Approved for RET Fusion–Positive Solid Tumors

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 ...

Selpercatinib Approved for RET Fusion-Positive Non-Small Cell Lung Cancer

Lyn Brook

FDA Updates

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...

Durvalumab Approved for Treatment of Biliary Tract Cancer

Lyn Brook

FDA Updates

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 c...

Pemigatinib Approved for Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement

Lyn Brook

FDA Updates

The FDA has approved pemigatinib (Pemazyre®, Incyte Corporation) for the treatment of relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with a fibroblast growth factor receptor 1 (FGFR1) rearrangement. This is the first approval and only targeted treatment for MLNs with a FGFR1 rearrangement. "Myeloid/lymphoid neoplasms with a FGFR1 rearrang...

Ibrutinib Approved for Pediatric Patients With Chronic Graft-Versus-Host Disease

Lyn Brook

FDA Updates

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 t...

Trastuzumab Deruxtecan First Approval for HER2-Mutant Non–Small Cell Lung Cancer

Lyn Brook

FDA Updates

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 sy...

Capmatinib Granted Regular Approval for Metastatic Non–Small Cell Lung Cancer

Lyn Brook

FDA Updates

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 ...

Darolutamide Approved for Treatment of Metastatic Hormone-Sensitive Prostate Cancer

Lyn Brook

FDA Updates

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 i...

Trastuzumab Deruxtecan Approved for Treatment of HER2-Low Breast Cancer

Lyn Brook

FDA Updates

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 ...

Crizotinib Approved for Treatment of ALK-Positive Inflammatory Myofibroblastic Tumors

Keira Smith

FDA Updates

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 activate...

Lisocabtagene Maraleucel Approved for Relapsed/Refractory Large B-Cell Lymphoma

Lyn Brook

FDA Updates

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 eligibl...

Dabrafenib Plus Trametinib Approved For Unresectable or Metastatic BRAF V600E Mutations

Lyn Brook

FDA Updates

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 R...

Umbralisib Withdrawn for Marginal Zone Lymphoma and Follicular Lymphoma

Lyn Brook

FDA Updates

The FDA has announced that it has withdrawn its approval of umbralisib (Ukoniq®, TG Therapeutics) for treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL). Umbralisib had previously been granted accelerated approval in February 2021 based on the UNITY-NHL trial (NCT02793583). The withdrawal of this treatment was determined due to ...

Nivolumab Plus Fluoropyrimidine and Platinum-Based Chemotherapy and Nivolumab Plus Ipilimumab Approved for Esophageal Squamous Cell Carcinoma

Lyn Brook

FDA Updates

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...

Accelerated Approval Granted to Tisagenlecleucel for Treatment of Relapsed or Refractory Follicular Lymphoma

Lyn Brook

FDA Updates

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 ...

Ivosidenib Approved in Combination With Azacitidine for Treatment of Acute Myeloid Leukemia

Lyn Brook

FDA Updates

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 product...

Azacitidine Approved for Treatment of Pediatric Patients with Newly Diagnosed Myelomonocytic Leukemia

Lyn Brook

FDA Updates

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, NF...

Fam-Trastuzumab Deruxtecan-nxki Approved for Treatment of Breast Cancer

Lyn Brook

FDA Updates

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, o...

Axicabtagene Ciloleucel Approved for Second-Line Treatment of Large B-Cell Lymphoma

Lyn Brook

FDA Updates

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 f...

Lutetium-177-PSMA-617 Approved for Treatment of Metastatic Castration-Resistant Prostate Cancer

Lyn Brook

FDA Updates

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 an...

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