Amgen AMGN announced that the FDA has approved its KRAS inhibitor, Lumakras (sotorasib), in combination with its anti-EGFR antibody, Vectibix (panitumumab), for treating KRAS G12C-mutated metastatic colorectal cancer (mCRC).

The regulatory body approved Lumakras plus Vectibix for treating KRAS G12C-mutated mCRC in adult patients who have previously received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

Lumakras is presently approved for treating advanced or metastatic non-small cell lung cancer (NSCLC). The drug was approved in the United States in May 2021 and in the EU (marketed as Lumykras) in January 2022.

In the past year, shares of Amgen have dropped 12.2% compared with the industry’s decline of 14.1%.

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Latest Nod Based on AMGN's CodeBreaK 300 Study

Lumakras’ approval for the mCRC indication was based on data from the phase III CodeBreaK 300 study, which evaluated Lumakras plus Vectibix versus the investigator's choice of therapy in KRAS G12C–mutated mCRC.

Data from the CodeBreaK 300 study showed that treatment with Lumakras plus Vectibix led to superior progression-free survival (PFS) versus the investigated standard-of-care (SOC) in KRAS G12C-mutated mCRC – the study’s primary endpoint.

The study evaluated two different doses of Lumakras (960 mg daily or 240 mg daily) in combination with Vectibix versus the investigator's choice of SOC (trifluridine and tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated mCRC.

Per management, the combo of Lumakras plus Vectibix is now the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to demonstrate superior PFS versus the investigated SOC.

Data from the CodeBreaK 300 study also showed that treatment with Lumakras plus Vectibix demonstrated favorable overall survival and overall response rate in treating KRAS G12C-mutated mCRC – the study's key secondary endpoints.

More Updates on AMGN's Lumakras

In the first nine months of 2024, Lumakras recorded sales worth $265 million, reflecting an increase of 30.5% on a year-over-year basis.

Label expansion studies on Lumakras in earlier lines of therapy, which have the potential to significantly expand the currently addressable patient population, are ongoing.

Amgen is also evaluating Lumakras in phase I and phase II studies for treating NSCLC as monotherapy and in combination with other therapies. Approval for expanded indications can potentially boost the drug’s sales in future quarters.

AMGN's Zacks Rank & Stocks to Consider

Amgen currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Voyager Therapeutics, Inc. VYGR, CytomX Therapeutics, Inc. CTMX and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Voyager Therapeutics’ loss per share have narrowed from $1.72 to $1.48 for 2025. In the past year, shares of VYGR have plunged 32.8%.

VYGR’s earnings beat estimates in each of the trailing four quarters, the average surprise being 120.87%.

In the past 60 days, estimates for CytomX Therapeutics’ loss per share have narrowed from 46 cents to 35 cents for 2025. In the past year, shares of CTMX have declined 48.5%.

CTMX’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 115.70%.

In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from $1.88 to $1.84 for 2025. In the past year, shares of CSTL have surged 26%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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