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Iovance (IOVA) to Seek FDA Nod for Melanoma Therapy in August
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Iovance Biotherapeutics (IOVA - Free Report) announced that it has received positive feedback from the FDA on Apr 1, 2022, with regard to the potency assays and assay matrix for its lead pipeline candidate, lifileucel, in melanoma.
The positive feedback from the regulatory agency movesIovance a step closer to its planned biologic license application (BLA) filing for lifileucel in metastatic melanoma. Although the company intends to complete the BLA filing by this August, it will request a pre-BLA meeting with the FDA later in July.
The FDA’s queries on potency assays for lifileucel, which began in 2020, have been one of the main reasons preventing IOVA from filing a BLA for lifileucel in melanoma indication. Alignment with the FDA on potency assays for a TIL therapy like lifileucel is necessary to support the BLA’s submission. In fact, until Iovance resolves the potency assay issue for lifileucel, IOVA cannot proceed with plans for regulatory filings in other indications, including cervical cancer.
Shares of Iovance were up 2.1% in after-market trading on Tuesday, following the news announcement. Yet, the stock has declined 13.3% so far this year in comparison with the industry’s 11.8% fall.
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Iovance also announced plans to start a phase III study evaluating lifileucel in combination with Merck’s (MRK - Free Report) blockbuster PD-1 inhibitor, Keytruda (pembrolizumab), in melanoma later this year. The late-stage study will evaluate the lifileucel-pembrolizumab combo as apotential treatment for immune checkpoint inhibitor naïve frontline metastatic melanoma. The company has already evaluated this combination in the given indication in a cohort of the phase II study (IOV-COM-202). Data from the cohort demonstrated an overall response rate of 67%.
A multi-center study, IOV-COM-202 is composed of seven cohorts evaluating Iovance’s TIL therapies in multiple settings and indications, both as a monotherapy and in combination with Keytruda or Bristol-Myers’ (BMY - Free Report) Opdivo/Yervoy.
A key revenue generator for Merck, Keytruda is approved for the treatment of many cancer indications globally. For the full year of 2021, Merck recorded $17.2 billion in sales from Keytruda. Merck is also evaluating Keytruda across a wide number of indications that are progressing well.
Opdivo and Yervoy are two of the many blockbuster drugs marketed by Bristol Myers and are key growth drivers of BMY’s top line. During full-year 2021, Bristol Myers generated $7.5 billion from Opdivo sales and recorded $2 billion as product revenues from Yervoy.
ProPhase Labs’ earnings per share estimates for 2022 have increased from 3 cents to 27 cents in the past 60 days. The same for 2023 has increased from 65 cents to 73 cents in the past 60 days. Shares of PRPH have risen 8.1% year to date.
Earnings of ProPhase Labs missed estimates in three of the last four quarters and beat the mark on one occasion, with the negative surprise being 157.7%.
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Iovance (IOVA) to Seek FDA Nod for Melanoma Therapy in August
Iovance Biotherapeutics (IOVA - Free Report) announced that it has received positive feedback from the FDA on Apr 1, 2022, with regard to the potency assays and assay matrix for its lead pipeline candidate, lifileucel, in melanoma.
The positive feedback from the regulatory agency movesIovance a step closer to its planned biologic license application (BLA) filing for lifileucel in metastatic melanoma. Although the company intends to complete the BLA filing by this August, it will request a pre-BLA meeting with the FDA later in July.
The FDA’s queries on potency assays for lifileucel, which began in 2020, have been one of the main reasons preventing IOVA from filing a BLA for lifileucel in melanoma indication. Alignment with the FDA on potency assays for a TIL therapy like lifileucel is necessary to support the BLA’s submission. In fact, until Iovance resolves the potency assay issue for lifileucel, IOVA cannot proceed with plans for regulatory filings in other indications, including cervical cancer.
Shares of Iovance were up 2.1% in after-market trading on Tuesday, following the news announcement. Yet, the stock has declined 13.3% so far this year in comparison with the industry’s 11.8% fall.
Image Source: Zacks Investment Research
Iovance also announced plans to start a phase III study evaluating lifileucel in combination with Merck’s (MRK - Free Report) blockbuster PD-1 inhibitor, Keytruda (pembrolizumab), in melanoma later this year. The late-stage study will evaluate the lifileucel-pembrolizumab combo as apotential treatment for immune checkpoint inhibitor naïve frontline metastatic melanoma. The company has already evaluated this combination in the given indication in a cohort of the phase II study (IOV-COM-202). Data from the cohort demonstrated an overall response rate of 67%.
A multi-center study, IOV-COM-202 is composed of seven cohorts evaluating Iovance’s TIL therapies in multiple settings and indications, both as a monotherapy and in combination with Keytruda or Bristol-Myers’ (BMY - Free Report) Opdivo/Yervoy.
A key revenue generator for Merck, Keytruda is approved for the treatment of many cancer indications globally. For the full year of 2021, Merck recorded $17.2 billion in sales from Keytruda. Merck is also evaluating Keytruda across a wide number of indications that are progressing well.
Opdivo and Yervoy are two of the many blockbuster drugs marketed by Bristol Myers and are key growth drivers of BMY’s top line. During full-year 2021, Bristol Myers generated $7.5 billion from Opdivo sales and recorded $2 billion as product revenues from Yervoy.
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
Zacks Rank & Stock to Consider
Iovance currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is ProPhase Labs (PRPH - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
ProPhase Labs’ earnings per share estimates for 2022 have increased from 3 cents to 27 cents in the past 60 days. The same for 2023 has increased from 65 cents to 73 cents in the past 60 days. Shares of PRPH have risen 8.1% year to date.
Earnings of ProPhase Labs missed estimates in three of the last four quarters and beat the mark on one occasion, with the negative surprise being 157.7%.