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Umbralisib Withdrawn for Marginal Zone Lymphoma and Follicular Lymphoma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The FDA has announced that it has withdrawn its approval of umbralisib (Ukoniq®, TG Therapeutics) for treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL).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...
Pembrolizumab Approved for Treatment of Advanced Endometrial Carcinoma
Lyn Brook
FDA Updates
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 appr...
Combination of Nivolumab and Relatlimab Approved for Unresectable or Metastatic Melanoma
Lyn Brook
FDA Updates
The FDA has approved the combination of nivolumab and relatlimab-rmbw (Opdualag™, Bristol-Myers Squibb) for patients with unresectable or metastatic melanoma. OpdualagTM is a fixed-dose dual immunotherapy combination of nivolumab, a programmed cell death protein 1 (PD-1)–blocking antibody, and relatlimab, a first-in-class human lymphocyte–activatio...
Olaparib Approved as Adjuvant Treatment for BRCA-Mutated High-Risk Early Breast Cancer
Keira Smith
FDA Updates
The FDA has approved olaparib (Lynparza®, AstraZeneca) for the adjuvant treatment of patients with deleterious or suspected deleterious germline BRCA–mutated, human epidermal growth factor receptor 2 (HER2)–negative high-risk early breast cancer who have previously received adjuvant or neoadjuvant chemotherapy. Olaparib is a poly–adenosine diphosph...
FDA Approves Nivolumab as Neoadjuvant Therapy for Resectable Non–Small Cell Lung Cancer
Eden Maack
FDA Updates
 The FDA has approved nivolumab (Opdivo®, Bristol-Myers Squibb) in combination with platinum doublet chemotherapy for the treatment of adult patients with early-stage, resectable non–small cell lung cancer (NSCLC). Nivolumab is a fully human programmed cell death ligand 1 (PD-L1)–targeted antibody, and its use is approved without regard for PD...
Pacritinib Approved for Intermediate- or High-Risk Myelofibrosis With Thrombocytopenia
Eden Maack
FDA Updates
The FDA has approved pacritinib (VonjoTM, CTI BioPharma) for the treatment of adult patients with intermediate- to high-risk primary or secondary myelofibrosis with a platelet count below 50x109/L. Pacritinib is a novel oral kinase inhibitor which inhibits Janus kinase 2 (JAK2) with minimal myelosuppression. Previous treatments available for interm...
FDA Approves Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma
Keira Smith
FDA Updates
The FDA has approved ciltacabtagene autoleucel (CarvyktiTM, Janssen Biotech) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least four prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. "Ciltacabtagene autoleucel (cilta-cel)...
FDA Approves Tebentafusp-Tebn for Uveal Melanoma
Selma Khenissi, MPS
FDA Updates
The FDA has approved tebentafusp-tebn (Kimmtrak®, Immunocore) for the treatment of patients with HLA-A*02:01–positive unresectable or metastatic uveal melanoma."Uveal melanoma is a disease that is distinct from cutaneous melanoma, with a low tumor mutational burden and a one-year overall survival of approximately 50% in patients with metastatic uve...
i3 Health and Oncology Data Advisor Announce ODACon 2022, a Rare Hematologic Malignancies Symposium
Keira Smith
Featured Exclusive
ROCHELLE PARK, NJ—January 12, 2022 – i3 Health and Oncology Data Advisor have announced that ODACon, a Rare Hematologic Malignancies Symposium, will be held on January 29, 2022. This 1-day virtual conference features 5 exclusive sessions on emerging data in hematologic malignancies, including acute lymphoblastic leukemia (ALL), Hodgkin lymphoma (HL...
FDA Approves Pembrolizumab for Adjuvant Treatment of Stage IIB or IIC Melanoma
Eden Maack
FDA Updates
The FDA has approved pembrolizumab (Keytruda®, Merck), a programmed death cell death protein 1 (PD-1)–blocking antibody, for the adjuvant treatment of adult and pediatric patients 12 years and older with stage IIB or IIC melanoma following complete resection. "Current standard of care for patients after resection of high-risk stage II melanoma is o...
FDA Approves Daratumumab Plus Hyaluronidase-Fihj, Carfilzomib, and Dexamethasone for Multiple Myeloma
Selma Khenissi, MPS
FDA Updates
The FDA has approved daratumumab plus hyaluronidase-fihj (Darlazex Faspro®, Janssen Biotech) in combination with carfilzomib (Kyprolis®, Amgen) plus dexamethasone for patients with relapsed/refractory multiple myeloma who had received 1 to 3 prior lines of therapy. "Daratumumab is a human immunoglobulin G kappa monoclonal antibody targeting CD...
FDA Approves Sirolimus Protein-Bound for Perivascular Epithelioid Cell Tumors
Selma Khenissi, MPS
FDA Updates
The FDA has approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro™, Aadi Bioscience) for patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor. "Malignant perivascular epithelioid cell tumor is a rare, aggressive sarcoma," wrote Andrew J. Wagner, MD, PhD, Medic...

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