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Eli Lilly (LLY) Gets FDA Nod for RET Inhibitor in Solid Tumors

Eli Lilly LLY announced that the FDA granted accelerated approval to Retevmo (selpercatinib) in adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion, regardless of tumor type. The drug has been approved to treat patients whose disease has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

Until now, Retevmo was approved under the accelerated pathway for patients with advanced RET-driven lung and thyroid cancers.

In the year so far, shares of Eli Lilly have increased 7.3% against the industry’s 5.1% fall.


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The approval is based on positive data from the pivotal phase I/II LIBRETTO-001 study, which evaluated selpercatinib across various tumor types in patients with RET-driven cancers. The primary endpoint was to determine the overall response rate (ORR), while secondary endpoints included duration of response (DOR).

The accelerated approval granted to Retevmo in solid tumors was based on 41 patients enrolled in the tumor-agnostic data set, which evaluated the drug in different cancer indications. Treatment with Retevmo demonstrated clinically meaningful and durable responses across various tumor types in patients with RET-driven cancers, including pancreatic, colon and other cancers. Overall data from the study showed that participants administered Retevmo achieved an ORR of 44% (including 39% partial response) at a median DOR of 24.5 months.

The FDA approval of the tumor-agnostic indication expands Retevmo’s patient base to include difficult-to-treat solid tumors, which was earlier only limited to metastatic non-small cell lung cancer (NSCLC) and advanced thyroid cancer patients. Retevmo is the first and the only RET inhibitor to receive approval for the treatment of advanced or metastatic solid tumors. We expect the expansion to help Eli Lilly generate significant revenue from the drug’s sales in the upcoming quarters.

In addition to the above-accelerated approval, the FDA converted the accelerated approval granted to Retevmo in NSCLC indication in May 2020 to full approval. Retevmo is approved to treat adults with locally advanced or metastatic NSCLC with a RET gene fusion. This full approval broadens Retevmo’s label to include patients withlocally advanced diseases.

The conversion to full approval is based on a data-set, which evaluated Retevmo in RET fusion-positive NSCLC patients who have either been treated with platinum chemotherapy or are treatment-naïve. While the treatment- naïve patients (n=69) achieved an ORR of 84%, the platinum chemotherapy-treated patients (n=247) achieved 61% ORR at median DORs of 20.2 months and 28.6 months, respectively.

 

Zacks Rank & Stock to Consider

Eli Lilly currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the overall healthcare sector are Kamada KMDA, Morphic MORF and Sanofi SNY. While Kamada and Morphic sport a Zacks Rank #1 (Strong Buy), Sanofi carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Kamada’s 2022 earnings per share have risen from 1 cent to 26 cents. Shares of Kamada have lost 31.9% in the year-to-date period.

The earnings of Kamada missed estimates in three of the last four quarters and beat the mark just once, witnessing a negative surprise of 212.50%, on average. In the last reported quarter, KMDA’s earnings beat estimates by 450%.

In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.38 to $1.80. Loss estimates for 2023 have narrowed from $3.91 to $3.62 during the same period. Shares of Morphic have lost 43% in the year-to-date period.

Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.

In the past 60 days, estimates for Sanofi’s 2022 earnings per share have increased from $4.09 to $4.14. Earnings estimates for 2023 have increased from $4.23 to $4.29 during the same period. Shares of Sanofi have lost 22.6% in the year-to-date period.

Earnings of Sanofi beat estimates in each of the last four quarters, witnessing a surprise of 9.37%, on average. In the last reported quarter, SNY delivered an earnings surprise of 8.24%.


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