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J&J (JNJ) Seeks FDA Approval for Myeloma Drug Teclistamab

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Johnson & Johnson (JNJ - Free Report) announced that it has submitted a Biologics License Application (BLA) to the FDA for its bispecific antibody candidate teclistamab. The BLA is seeking an approval for the candidate as a potential treatment of elapsed or refractory (R/R) multiple myeloma (MM).

J&J believes that although there are several treatment options available for MM patients, the unmet need remains very high.

The BLA includes data from the open-label, multicenter phase I/II study MajesTEC-1 that evaluated the safety and efficacy of teclistamab in adult patients with R/RMM. Data from the study following a median follow-up of eight months demonstrated that treatment with teclistamab monotherapy achieved an objective response rate (ORR) of 62% in heavily pretreated MM patients who received at least three prior lines of therapy.

The proportion of patients treated with the candidate having achieved a very good partial response or better was 58%, a complete response was 29% and a stringent complete response was 21%. The monotherapy achieved MRD negativity in 25% of patients in the study with intent to treat. 42% of patients who achieved a complete response also achieved MRD negativity.

Among the study participants, 59% survived without any disease progression at the follow-up of nine months.

Shares of J&J have rallied 9% so far this year compared with the industry’s increase of 21.1%.

Zacks Investment ResearchImage Source: Zacks Investment Research

J&J is also developing teclistamab in combination with chemotherapies or other anti-cancer therapies for treating R/RMM.

We note that J&J also developed a CAR-T therapy called ciltacabtagene autoleucel for treating R/RMM. The candidate is currently under review with the FDA. A decision is expected in February next year.

Per the press release, in the United States, an estimated 35,000 people are estimated to be diagnosed with MM in 2021, of which around 12,000 people will die from the disease. Hence, if successfully developed, and upon potential approval, cilta-cel can be a highly active, dual-binding BCMA CAR-T therapy to serve patients with relapsed/refractory MM.

Zacks Rank & Stocks to Consider

J&J currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the biotech sector are GlaxoSmithKline (GSK - Free Report) , Gilead (GILD - Free Report) and Repligen (RGEN - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Earnings per share estimates for Glaxo have improved from $2.90 to $3.05 for 2021 and from $3.15 to $3.25 for 2022 in the past 60 days.

Shares of Glaxo have risen 20.7% so far this year.

Earnings per share estimates for Gileadhave moved north from $7.89 to $8.07 for 2021 and from $6.74 to $6.75 for 2022 in the past 60 days.

Gilead delivered an earnings surprise of 15.79%, on average, in the last four quarters.

Earnings per share estimates for Repligen have moved north from $2.86 to $2.90 for 2021 and from $3.12 to $3.21 for 2022 in the past 60 days.

Repligen’s stock has surged 34.6% so far this year.