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FDA Updates for Week of Nov. 7, 2022


The FDA approved several new therapies for cancers, including the combination of Imfinzi and Imjudo to treat lung cancer, Libtayo for second indication in lung cancer, and Adcetris for younger patients with Hodgkin lymphoma. In COVID-19 news, the agency issued an EUA for Kineret for hospitalized, but indicated bebtelovimab does not neutralize new omicron subvariants. The regulatory agency also accepted NDAs for a Parkinson’s disease therapy and for a therapy used for stem cell mobilization.

FDA clears Imfinzi/Imjudo combination for lung cancer.

The FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy to treat adult patients with metastatic non-small cell lung cancer (NSCLC). Imjudo is a monoclonal antibody that targets the activity CTLA-4; Imfinzi is a PD-L1 inhibitor.

The approval was based on the results from the POSEIDON phase 3 trial. Patients treated with a limited course of five cycles of the anti-CTLA-4 antibody Imjudo added to Imfinzi plus four cycles of platinum-based chemotherapy experienced a 23% reduction in the risk of death versus a range of chemotherapy options. An estimated 33% of patients were alive at two years versus 22% for chemotherapy. This treatment combination also reduced the risk of disease progression or death by 28% compared with chemotherapy alone.

Last month, the FDA approved the combination of Imjudo and Imfinzi to treat patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.

FDA approves Adcetris for younger patients with Hodgkin lymphoma.

The FDA has approved Adcetris (brentuximab vedotin) for the treatment of pediatric patients two years and older with previously untreated high-risk classical Hodgkin lymphoma (cHL). It is approved to be used in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.

Hodgkin lymphoma is blood cancer of the lymphocytes. Classic Hodgkin lymphoma (cHL) accounts for more than 9 in 10 cases of Hodgkin lymphoma in developed countries, according to the American Cancer Society. About one-third of all Hodgkin lymphoma patients are classified as high risk.

Adcetris, jointly developed by Seagen and Takeda, is a CD30 directed antibody-drug conjugate. It is currently available for several indications, including adult patients with previously untreated Stage III/IV cHL in combination with doxorubicin, vinblastine, and dacarbazine, cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation, adult patients systemic anaplastic large cell lymphoma, and Adult patients with primary cutaneous anaplastic large cell lymphoma.

FDA approves Libtayo for second indication in advanced lung cancer.

The FDA has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. Patients may be treated with this combination irrespective of PD-L1 expression.

Developed by Regeneron, Libtayo is fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. It is also approved to treat patients with advanced cutaneous squamous cell carcinoma, basal cell carcinoma, advanced non-small cell lung cancer without chemotherapy.

The recent FDA approval is based on data from the global phase 3 trial, EMPOWER-Lung 3, that investigated Libtayo in combination with a physician’s choice of a platinum-doublet chemotherapy, compared with platinum-doublet chemotherapy alone. The study found that Libtayo resulted in a median overall survival of 22 month versus 13 months chemotherapy, representing a 29% relative reduction in the risk of death. Median grogression-free survival for Libtayo was eight months versus five months for chemotherapy, representing a 44% reduction in the risk of disease progression.

FDA issues EUA for Kineret for hospitalized COVID-19 patients.

FDA has issued an emergency use authorization (EUA) for Sobi’s Kineret (anakinra) injection for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure.

Kineret is an Interleukin-1 (IL-1) receptor antagonist. IL-1 is involved in inflammatory diseases and IL-1 is linked to acute severe lung inflammation in COVID-19. Kineret is currently FDA-approved to treat patients with rheumatoid arthritis; cryopyrin-associated periodic syndromes, a rare, hereditary inflammatory disorder; and deficiency of IL-1 receptor antagonist, a rare life-threatening autoinflammatory disease.

The EUA was based on data from the SAVE-MORE trial of adult patients with COVID-19 pneumonia who were at risk of developing severe respiratory failure. The trial enrolled 594 patients; 189 patients were randomized to the placebo plus standard of care arm and 405 patients to the Kineret plus standard of care arm for 10 days. At the start of treatment, 91% of patients had severe COVID-19 pneumonia and required low- or high- flow supplementary oxygen.

FDA accepts NDA for novel Parkinson’s disease therapy.

The FDA has accepted for review Amneal Pharmaceuticals’ new drug application (NDA) for IPX203 to treat Parkinson’s disease (PD). The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of June 30, 2023. IPX203 is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules.

The submission is based on results from the pivotal phase 3 RISE-PD clinical trial demonstrating more “Good On” time compared with immediate-release carbidopa/levodopa. The trial also showed this was the case when IPX203 was dosed on average three times per day and immediate-release carbidopa/levodopa was dosed on average five times per day. The trial also showed that subjects on IPX203 demonstrated significantly less “Off” time compared with immediate-release carbidopa/levodopa.

Amneal’s therapy contains extended-release beads that consist of levodopa, coated with a sustained release polymer, to allow for slow release of the drug. This formulation is distinct from Rytary extended-release capsules, Amneal’s extended-release carbidopa/levodopa treatment for Parkinson’s disease approved by the FDA in 2015.

FDA accepts NDA for Aphexda for use in stem cell mobilization.

The FDA has accepted for review BioLineRx’s new drug application (NDA) for Aphexda (motixafortide) in stem cell mobilization for autologous transplantation in patients with multiple myeloma. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of Sept. 9, 2023.

Autologous stem cell transplantation is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma. The current standard of care includes the administration of five to eight daily doses of granulocyte colony stimulating factor (G-CSF), with or without one to four doses of Sanofi’s Mozobil (plerixafor), an immunostimulant used to mobilize hematopoietic stem cells in cancer patients into the bloodstream.

The application is supported by the results from the GENESIS phase 3 trial of motixafortide in combination with granulocyte colony-stimulating factor (G-CSF) treatment (versus placebo on top of G-CSF) in stem cell mobilization for autologous transplantation in multiple myeloma patients. The study met all primary and secondary endpoints with a very high degree of statistical significance. In the study, about 90% of patients in went directly to transplantation after mobilizing the optimal number of stem cells following only one administration of motixafortide with G-CSF, compared with less than 10% of those receiving G-CSF alone.

FDA: Bebtelovimab does not neutralize new omicron subvariants.

Bebtelovimab is not expected to neutralize COVID-19 omicron subvariants BQ.1 and BQ.1.1, the FDA said in an updated Healthcare Provider Fact Sheet for bebtelovimab. Bebtelovimab is a monoclonal antibody developed by AbCellera and Eli Lilly to treat COVID-19. The agency granted the monoclonal antibody emergency use authorization to treat mild-to-moderate COVID-19 in February 2022.

The FDA said bebtelovimab is not authorized to treat mild-to-moderate COVID-19 in geographic regions “where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information.” The agency recommends prescribers monitor CDC regional variant frequency data and refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants, particularly omicron subvariants BQ.1 and BQ.1.1.

Several treatments are authorized or approved to treat certain patients with mild-to-moderate COVID-19 and are expected to retain activity against currently circulating variants, including omicron subvariants BQ.1 and BQ.1.1, the FDA said.

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