FLASCO News

Incyte

FDA approves ruxolitinib for chronic graft-versus-host disease

On September 22, 2021, the Food and Drug Administration approved ruxolitinib (Jakafi, Incyte Corp.) for chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Efficacy was evaluated in REACH-3 (NCT03112603), a randomized, open-label, multicenter clinical trial of ruxolitinib compared to best...

FLASCO

FDA approves cabozantinib for differentiated thyroid cancer

On September 17, 2021, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine. Efficacy was evaluated in COSMIC-311,...

Seagen

FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer

On September 20, 2021, the Food and Drug Administration granted accelerated approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval was based on innovaTV 204, an open-label, multicenter, single-arm clinical trial (NCT03438396)....

FMA

How the new DNA privacy law could affect your practice

Under the Protecting DNA Privacy Act (HB 833), signed into law by Gov. Ron DeSantis on June 29, collecting or submitting another person’s DNA sample for analysis without his or her express consent now constitutes a second-degree felony in the state of Florida. While this legislation was intended to prevent the unauthorized use of personal DNA information,...

Takeda

FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

On September 15, 2021, the Food and Drug Administration granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals, Inc.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based...

Beigene

FDA approves zanubrutinib for Waldenström’s macroglobulinemia

On August 31, 2021, the Food and Drug Administration approved zanubrutinib (Brukinsa, BeiGene) for adult patients with Waldenström’s macroglobulinemia (WM). Zanubrutinib was investigated in ASPEN (NCT03053440), a randomized, active control, open-label trial, comparing zanubrutinib and ibrutinib in patients with MYD88 L265P mutation (MYD88MUT) WM. Patients in Cohort 1 (n=201) were randomized 1:1 to receive zanubrutinib...

FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma

On August 25, 2021, the Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Today, the FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic...

Bristol Myers Squibb

FDA approves nivolumab for adjuvant treatment of urothelial carcinoma

On August 19, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. This is the first FDA approval for adjuvant treatment of patients with high-risk UC. The results supporting this approval...

GlaxoSmithKline

FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors

On August 17, 2021, the Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. Today, the FDA...

Merck

FDA approves belzutifan for cancers associated with von Hippel-Lindau disease

On August 13, 2021, the Food and Drug Administration approved belzutifan (Welireg, Merck), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Belzutifan was investigated in the ongoing Study...

Merck

FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer

On July 26, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. FDA also granted regular approval to pembrolizumab in combination with chemotherapy for patients with locally recurrent...

Merck

FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma

On July 21, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or...

FLASCO

FDA approves belumosudil for chronic graft-versus-host disease

On July 16, 2021, the Food and Drug Administration approved belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. Efficacy was evaluated in KD025-213 (NCT03640481), a randomized, open-label, multicenter dose-ranging...

FLASCO

FDA Approves Enfortumab Vedotin For Locally Advanced/Metastatic Urothelial Carcinoma

Enfortumab vedotin-ejfv has been approved by the FDA for locally advanced or metastatic urothelial cancer. The FDA has approved enfortumab vedotin-ejfv (Padcev) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously undergone treatment with a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy or who are otherwise ineligible for...

Janssen | Johnson & Johnson

FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma

On July 9, 2021, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. Efficacy was evaluated in APOLLO (NCT03180736), an open-label, active-controlled...

Astellas

FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer

On July 9, 2021, the Food and Drug Administration approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or are ineligible for...

Jazz Pharmaceuticals

Jazz Pharmaceuticals Announces U.S. FDA Approval of Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Approval under U.S. FDA’s Real-Time Oncology Review program represents an important therapeutic advance for pediatric and adult patients who develop hypersensitivity to E. coli-derived asparaginase treatmentsRylaze is expected to become commercially available in the U.S. in mid-JulyCompany to host investor webcast in July; details to follow DUBLIN, June 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced...

Jazz Pharmaceuticals

FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer

Today, the U.S. Food and Drug Administration approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment. The only other FDA-approved drug for such patients...

Jazz Pharmaceuticals

FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma

On June 30, 2021, the Food and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)-rywn) (Rylaze, Jazz Pharmaceuticals, Inc.) as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase. Efficacy...

Blueprint Medicines

FDA approves avapritinib for advanced systemic mastocytosis

On June 16, 2021, the Food and Drug Administration approved avapritinib (Ayvakit™, Blueprint Medicines Corp.) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). Efficacy was evaluated in EXPLORER (NCT02561988) and PATHFINDER (NCT03580655), two multi-center, single-arm,...

FDA

FDA warns that vapors from alcohol-based hand sanitizers can have side effects

The U.S. Food and Drug Administration (FDA) is warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin. These symptoms are likely to have occurred because of vapors from the hand sanitizer, potentially from exposure in enclosed spaces or places with poor air circulation. We have...

FLASCO

Disparities in Cancer Care and Health Equity Summit 2021

FLASCO is bringing together leaders in cancer disparities and health equity to advance the understanding of and promote their elimination. Cancer disparities represent a major public health problem in our state, and across the country. Professionals from academic, industry, and the community are coming together, with the shared mission of closing health equity gaps, and...

FLASCO Foundation

Support FLASCO Foundation

Not only is Memorial Day an important time to remember those who have given the ultimate sacrifice to protect our country, but it is a day to spend quality time with family and friends as a kickoff to summer. The holiday weekend is usually filled with large gatherings, parades, picnics, or weekend trips. Obviously, in...

FDA

FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma

On May 28, 2021, the Food and Drug Administration granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics, Inc.), a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. The FDA also approved FoundationOne®...

Amgen

FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLC

On May 28, 2021, the Food and Drug Administration granted accelerated approval to sotorasib (Lumakras™, Amgen, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C ‑mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA ‑approved test, who have received at least one prior systemic therapy. FDA also...

FDA

FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer

On May 21, 2021, the Food and Drug Administration granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.), a bispecific antibody directed against epidermal growth factor (EGF) and MET receptors, for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected...

Bristol Myers Squibb

FDA approves nivolumab for resected esophageal or GEJ cancer

On May 20, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. Efficacy was evaluated in CHECKMATE-577 (NCT02743494), a randomized, multicenter, double-blind trial in 794 patients with completely resected (negative margins) esophageal...

Merck

FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer

On May 5, 2021, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Approval was based on the prespecified interim analysis of...

GlaxoSmithKline

FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer

On April 22, 2021, the Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior  platinum-containing regimen. Efficacy was evaluated based on cohort (A1) in GARNET...

FDA

FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma

On April 23, 2021, the Food and Drug Administration granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising...

Bristol Myers Squibb

FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma

On April 16, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Efficacy was evaluated in CHECKMATE-649 (NCT02872116), a randomized, multicenter, open-label trial that enrolled 1,581 patients with previously untreated advanced or metastatic...

Immunomedics

FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer

On April 13, 2021, the Food and Drug Administration granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. Efficacy and safety were evaluated in TROPHY...

FDA

FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer

On April 7, 2021, the Food and Drug Administration granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. In April 2020, sacituzumab govitecan received accelerated approval...

FDA

FDA approves new dosing regimen for cetuximab

On April 6, 2021, the Food and Drug Administration approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (Erbitux, ImClone LLC) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN). This approval provides for a biweekly...

FDA

FDA approves isatuximab-irfc for multiple myeloma

On March 31, 2021, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U.S. LLC) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. The efficacy and safety of isatuximab-irfc in combination with carfilzomib and dexamethasone...

Bristol Myers Squibb

FDA approves idecabtagene vicleucel for multiple myeloma

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the...

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